Job Description

In this role you have the opportunity to

make a difference by providing strategic direction and leadership regarding all aspects of the Quality and Regulatory areas at TOMTEC in Unterschleißheim. By doing so, you help to ensure state-of-the-art medical /clinical software applications that maximizes the benefit of digital healthcare for both physicians and patients.

Responsibilities

• Identifying and implementing standard methodologies to improve efficiency and maintain compliance and lead the function in continuous process improvement.
• Leading, developing and mentoring a team of Q&R professionals responsible for TOMTEC solutions.
• Reviewing and maintaining an effective Quality Management System.
• Ensuring that regulatory strategies adequately support product development activities and result in the timely approval of new and revised products.
• Representing the business during any audit, internal or external. Driving compliance across all functions of the business and ensuring preparedness for any audits.
• Working closely with quality and regulatory leaders of our ultrasound business in the US and with the leadership team at TOMTEC.
• Maintaining productive working relationships with external regulatory bodies.
• Implementing appropriate activities to ensure regulatory compliance and adherence effectiveness of the quality system such as: complaint handling, corrective and preventive action, and the internal audit program.
• Monitoring external changes to the regulatory environment to ensure the continued compliance of the quality system.

You are a part of

the Management Team at TOMTEC in Unterschleißheim and collaborate closely with the ultrasound quality and regulatory leaders in the US. In this role you will report into the Sr. Director Ultrasound Quality & Regulatory.

To succeed in this role, you should have the following skills and experiences

• Minimum of a Bachelor's degree in Science, Engineering or similar technical discipline.
• Minimum of 10 years working experience in the area of medical device quality, experience in medical software quality preferred.
• Minimum of 5 years leading experience.
• Experience with FDA and other worldwide standards and regulations as well as in leading and supporting both internal and external audits.
• Experience in maintaining an effective Quality Management System.  
• Strong stakeholder management and communication skills.
• Solution-driven, customer-focused and team-oriented.
• Fluent English skills, German skills are a plus.

In return, we offer

• Working in a motivated team
• Versatile, challenging tasks in a growing company in an international environment
• An innovative environment with the chance to evolve
• An excellent working atmosphere with flat hierarchies and short decision makings
• An attractive and dynamic salary package, excellent employee benefits and supplementary pension
• Flexible trust-based working hours, massages, sports courses, regular team events and much more

Contact

Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/jobs-and-careers/job/Munich/Head-of-Quality-and-Regulatory--m-w-d--for-Medical-Software-at-TOMTEC-in-Munich_321275-1

TOMTEC Imaging Systems GmbH ist internationaler Technologieführer für Software-Lösungen im Bereich medizinische Bildverarbeitung und medizinisches Informationsmanagement. Seit Juli 2017 gehört TOMTEC zur Philips Ultraschall Unternehmensgruppe, führt jedoch sein herstellerunabhängiges Produktportfolio fort.

Vor 25 Jahren haben wir bereits begonnen, Maßstäbe in der Entwicklung von 4D Ultraschalldiagnostik zu setzen. Unsere langjährige Erfahrung macht uns zum bevorzugten Partner für Kliniken und Unternehmen der Healthcare IT Branche. Die führenden Ultraschallgerätehersteller vertrauen auf unsere Technologie Expertise. Über 100 Mitarbeiter entwickeln, testen und optimieren kontinuierlich unsere Applikationen am Hauptsitz Unterschleißheim/München und am Standort Fulda. Über unsere US-Tochtergesellschaft TOMTEC CORPORATION bedienen wir den amerikanischen Markt.    

Ihre Herausforderung

Als Software Test Engineer übernehmen Sie Verantwortung für die Qualität und die Zuverlässigkeit unserer medizinischen Software.

Sie arbeiten eigenverantwortlich in einem agilen Entwicklungsteam mit Kollegen unterschiedlicher Fachbereiche zusammen und sind maßgeblich daran beteiligt, unser Softwareprodukt zur Release-Reife zu bringen.                                                                         

Aufgabenstellung

• Sie erstellen selbstständig Testspezifikationen und Testfälle basierend auf der Produktspezifikation unserer Softwaremodule.
• Sie führen diese aus, protokollieren die Ergebnisse und erstellen die komplette Testdokumentation.
• Sie prüfen unsere Software im Rahmen von manuellen Akzeptanz- und explorativen Tests.
• Sie Erstellen und Pflegen automatisierte Akzeptanz- und Systemtest.
• Sie erfassen, analysieren, dokumentieren und verfolgen Produktfehler.
• Sie sind verantwortlich für die Auswahl geeigneter Test-Tools und das Aufsetzten einer definierten Testumgebung.

Ihr Team

Sie sind Teil von TOMTEC Products & Technology und erweitern hier das Team Reporting & Measurements. Zusammen mit Ihren Teamkollegen sind sie verantwortlich für den gesamten Entwicklungsprozess unserer klinischen Applikation zur Befundgenerierung und Messwertverwaltung.

Unser Angebot

• Arbeit in einem hoch motivierten Team
• Vielseitige und herausfordernde Aufgaben in einem expandierenden Unternehmen im internationalen Umfeld
• Eine innovative Umgebung, in der Sie sich weiterentwickeln können
• Ein ausgezeichnetes Betriebsklima mit flachen Hierarchien und kurzen Entscheidungswegen
• Ein attraktives, dynamisches Gehaltsmodell, vorbildliche Sozialleistungen und eine zusätzliche Altersvorsorge
•     Flexible Vertrauensarbeitszeit, Massage, Sportangebote, regelmäßige Team-Events und vieles mehr…

Was wir suchen

• Sie haben ein abgeschlossenes technisches Studium, idealerweise im Fachbereich medizinische Informatik / Medizintechnik, oder eine vergleichbare Ausbildung und konnten bereits erste Berufserfahrung sammeln.
• Sie bringen ein exzellentes Verständnis und eine Leidenschaft für Software-Anwendungen mit.
• Sie haben ein hohes Qualitätsbewusstsein, verfolgen Ihre Ziele gewissenhaft und zeigen sich gerne eigenverantwortlich.
• Sie sind kommunikationsfreudig und arbeiten gerne im Team.
• Idealerweise haben Sie bereits Vorkenntnisse im Bereich Medizin oder Medizintechnik.
• Sie sprechen Deutsch und können sicher auf Englisch kommunizieren.

Kontakt
Interessiert? Bitte bewerben Sie sich online über das Philips Portal – My HR – Karriere unter Angabe der Stellen ID:

https://philips.wd3.myworkdayjobs.com/Internal-Job-Postings-List-for-Philips-Contingent-Workers/job/Unterschleissheim/Software-Test-Engineer--m-f-d--for-Medical-Software-Solution_321358

Job Description

TOMTEC IMAGING SYSTEMS GMBH, with headquarter located in Munich / Germany, is a worldwide leader for medical image software solutions. Specialized in cardiology it offers state-of-the-art solutions for clinical customers and industry partners. The products encompass a wide range of 2D and 3D/4D technology for visualization, automated analysis, quantification, reporting and image management. TOMTEC products are available for adult and pediatric cardiology, obstetrics, gynecology, radiology and vascular diagnostics. Moreover, TOMTEC offers a sustainable full-service component in sales and an education program with best-practice sharing among professionals. The company claim "Excellence in Digital Healthcare" represents striving for excellent image and analysis quality, ease-of-use, reproducibility of automated measurements and an all-around service- and education offering. The company maintains close working relationships with many leading universities and research institutes around the world. In July 2017, TOMTEC became a part of the Philips Ultrasound Business group. However, TOMTEC is continuing its vendor independent product portfolio.

In this role, you have the opportunity

to actively contribute your knowledge and ideas in order to guarantee the qualitative requirements of our TOMTEC products (stand-alone software).

You will be responsible for the following topics

• Editing/ creation of Complaint Files
• Processing of CAPA as well as monitoring and effectiveness testing of CAPA
• Suppliermanagement
• Implementation and documentation of training courses
• Verification and introduction of QMS relevant requirements of partners and customers into the QMS as well as introduction/maintenance of further documentation/records in the QMS
• Implementation of process validation and process change management
• Participation in and performance of (external) audits
• Carrying out trend analyses and introducing and monitoring indicators

You are part of

our Quality and Regulatory Team at TOMTEC and report to Manager Q&R. You also work with international colleagues and authorities and exchange information with the Sales and Marketing team.  

To be successful in this position you need the following knowledge and experience

• Successfully completed studies in technical or scientific fields, e.g. medical technology or comparable educational background
• At least 5 years professional experience in the quality area of a medical device manufacturer
• Experience in software development an advantage
• Experience as auditor
• Analytical, independent and structured way of working
• Very good communication skills and distinctive team player characteristics
• Excellent knowledge of German and English (written and oral) 

Therefore we offer you 

• Working at one of the top rated employers in Bavaria in a motivated team.
• The opportunity to take ownership and drive your part of the solution.
• Versatile, challenging tasks in a growing company in an international environment.
• An innovative environment with the chance to evolve.
• An excellent working atmosphere with flat hierarchies and short decision paths.
• A family atmosphere.
• An attractive and dynamic salary package, excellent employee benefits and supplementary pension.
• Flexible trust-based working hours, massages, sports courses, language courses, regular team events and much more

Contact
Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/en-US/jobs-and-careers/job/Unterschleissheim/Quality-Specialist--m-w-d--fr-medizinische-Software-bei-TOMTEC-in-Mnchen_314572-1

In dieser Position haben Sie die Möglichkeit,

sich aktiv mit Ihrem Wissen und Ihren Ideen einzubringen, um die Sicherstellung der qualitativen Anforderungen an unsere TOMTEC-Produkte (stand-alone Software) zu gewährleisten.

Für folgende Themen bekommen Sie die Verantwortung

• Einführung und Aufrechterhalten von normativen und regulatorischen Anforderungen im Bereich Design & Development
• Durchführung von Auswertungen und Festlegen von Kennzahlen im Bereich Design & Development
• Verantwortung für Risiko-Management und Usability im Sinne von QM
• Mitwirken/Beratung bei der Clinical Evaluation
• Prozesserstellung und –Aufrechterhaltung sowie Ansprechpartner dazu in Audits
• Durchführung von Software Tool Validierungen
• Verantwortung für das zur Verfügung stellen von notwendigen regulatorischen Dokumenten sowie enge Zusammenarbeit mit Regulatory Affairs
• Planung und Überprüfung  von CAPAs im Bereich Design & Development
• Unterstützung bei der Erstellung von Complaint Files und Beratung in Besprechungen zur Patientensicherheit
• Durchführung von Schulungen

Sie sind Teil von
unserem Quality and Regulatory Team bei TOMTEC und berichten an die Managerin Q&R. Sie arbeiten darüber hinaus mit internationalen Kollegen und Behörden zusammen und tauschen sich mit dem Sales und Marketing Team aus.

Um in dieser Position erfolgreich zu sein, benötigen Sie folgende Kenntnisse und Erfahrungen

• Erfolgreich abgeschlossenes Studium im technischen bzw. naturwissenschaftlichen Bereich, z. B. Medizintechnik oder vergleichbarer Ausbildungshintergrund
• Mindestens 5 Jahre Berufserfahrung in einer vergleichbaren Position; insbesondere im Bereich Softwareentwicklung, idealerweise im medizinischen Bereich
• Mehrjährige Berufserfahrung im Quality Management für Medizinprodukte, insbesondere im Bereich Design & Development
• Exzellentes Verständnis von und Freude an strukturierten Vorgehensweisen
• Sehr gute Kommunikationsfähigkeit und ausgeprägte Teamplayereigenschaften
• Freude an der Weitergabe von Wissen und Informationen
• Hervorragende Deutsch- und Englischkenntnisse (schriftlich und mündlich)

Dafür bieten wir Ihnen

• Arbeit in einem motivierten Team
• Vielseitige, herausfordernde Aufgaben in einem expandierenden Unternehmen im internationalen Umfeld
• Eine innovative Umgebung, in der Sie sich weiterentwickeln können
• Ein ausgezeichnetes Betriebsklima mit flachen Hierarchien und kurzen Entscheidungswegen
• Ein attraktives, dynamisches Gehaltsmodell, vorbildliche Sozialleistungen und eine zusätzliche Altersversorgung
• Flexible Vertrauensarbeitszeit, Massage, Sportangebote, regelmäßige Team-Events und vieles mehr

Kontakt
Interessiert? Bitte bewerben Sie sich über das Philips Online-Portal:

https://philips.wd3.myworkdayjobs.com/jobs-and-careers/job/Unterschleissheim/Quality-Engineer--m-w--fr-medizinische-Software-bei-TOMTEC-in-Mnchen_285595

Job Description

TOMTEC IMAGING SYSTEMS GMBH, with headquarter located in Munich / Germany, is a worldwide leader for medical image software solutions. Specialized in cardiology it offers state-of-the-art solutions for clinical customers and industry partners.

The products encompass a wide range of 2D and 3D/4D technology for visualization, automated analysis, quantification, reporting and image management. TOMTEC products are available for adult and pediatric cardiology, obstetrics, gynecology, radiology and vascular diagnostics. Moreover, TOMTEC offers a sustainable full-service component in sales and an education program with best-practice sharing among professionals.

In July 2017, TOMTEC became a part of the Philips Ultrasound Business group.  However, TOMTEC is continuing its vendor independent product portfolio.

Your role

As part of the Clinical Innovations team you can enhance your knowledge and gain practical experience in computer science.

A challenging task

You will implement and adapt algorithms that process medical data, calculations of models and measurement data. 

• A convincing background
• You have experience in software development with MatLab or Python
• Desirably you have knowledge of processing and visualizing 2D to 4D image data 
• You are a student of computer science or a similar field (e.g. engineering, technomathematics) 

What we offer

• Working in a motivated team
• Versatile, challenging tasks in a growing company in an international environment
• An innovative environment with the chance to evolve
• An excellent working atmosphere 
• Flexible trust-based working hours, sports courses, regular team events and much more 

Contact

Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/de-DE/jobs-and-careers/job/Unterschleissheim/Interns---Working-Students---Bachelor-or-Master-Thesis--m-f----TOMTEC---MUNICH_288618

Job Description

TOMTEC IMAGING SYSTEMS GMBH is an international technology leader for software solutions in the medical image processing and medical information management area. Founded in 1990, TOMTEC has a global presence with offices in the U.S., Europe and Asia. Since 2017, TOMTEC with its over 140 employees is part of the Philips Ultrasound Business Group. TOMTEC offers vendor-neutral solutions that advance the state of the art in 3d rendering, image processing and artificial intelligence for health care imaging workflows. The main focus is in ultrasound image analysis, hospital information technology and automated diagnosis.

Our Munich based, agile team builds and maintains backend as well as frontend components for our TOMTEC-ARENA product (https://www.tomtec.de/products/image-management/). Your focus will be on the development of the TypeScript/Angular based frontend but you also have an interest in improving the interplay between the frontend and the Java/Spring/Tomcat based backend.

A challenging task

As Experienced Software Developer – Angular / TypeScript / Java you will take ownership of the patient study management and administration portions of the web frontend. You will design (UX), implement and deliver new features within our cross-functional, agile team. Our team collaborates with other development teams to build the components that make up the TOMTEC-ARENA product. Design changes and new product features are developed in close cooperation with our team’s product manager. In addition, you will contribute and implement architectural goals as well as refine best practices for the frontend and coordinate with different teams working on other frontend components on a technical level.

The team’s working language is German and English. If you don't know German – TOMTEC will provide German classes but a desire to learn is required.

A convincing background

• You have at least a bachelor’s degree in Computer Science, or equivalent experience and at least 3 years of professional experience building software.
• You have a good understanding of the web technology stack, including HTTP, HTML, CSS, JavaScript and REST Services.
• You have worked extensively with Angular and TypeScript in medium to large projects.
• Navigating in a large code base and cooperating with other developers is no challenge for you.
• Having worked with other OO languages such as Java and a basic understanding of how the frontend interacts with the Tomcat/Spring based backend is highly appreciated.
• Practicing state of the art coding standards like Clean Code, TDD and continuous integration is natural for you.
• A willingness to learn new things, take ownership and to communicate proactively is expected.
• You share our attitude towards software development as a craft, constantly
•  expanding your personal toolbox.

Your responsibilities

• You will design, implement, test and deliver new features within a cross-functional, agile team.
• You challenge the status quo and continuously improve architecture, code and tools to ensure high quality software delivery
• You own your solution and will be responsible from development to delivery to operations on customer site.
• You collaborate with fellow frontend and back end developers and coordinate development of the components you are responsible for with stakeholders from different teams that have overlapping concerns.
• You will ensure compliance to our guidelines and the regulatory requirements.

What we offer

• Working at one of the top rated employers in Bavaria in a motivated team.
• The opportunity to take ownership and drive your part of the solution.
• Versatile, challenging tasks in a growing company in an international environment.
• An innovative environment with the chance to evolve.
• An excellent working atmosphere with flat hierarchies and short decision paths.
• A family atmosphere.
• An attractive and dynamic salary package, excellent employee benefits and supplementary pension.
• Flexible trust-based working hours, massages, sports courses, language courses, regular team events and much more.

Contact

Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/jobs-and-careers/job/Unterschleissheim/Experienced-Software-Developer---Angular---TypeScript---Java---Munich--m-f-d-_299629-1

Job Title

Working Student (m/f/d) for Quality Management & Regulatory Affairs

Job Description

TOMTEC IMAGING SYSTEMS GMBH, with headquarter located in Munich / Germany, is a worldwide leader for medical image software solutions. Specialized in cardiology it offers state-of-the-art solutions for clinical customers and industry partners. The products encompass a wide range of 2D and 3D/4D technology for visualization, automated analysis, quantification, reporting and image management. TOMTEC products are available for adult and pediatric cardiology, obstetrics, gynecology, radiology and vascular diagnostics. Moreover, TOMTEC offers a sustainable full-service component in sales and an education program with best-practice sharing among professionals. The company claim "Excellence in Digital Healthcare" represents striving for excellent image and analysis quality, ease-of-use, reproducibility of automated measurements and an all-around service- and education offering. The company maintains close working relationships with many leading universities and research institutes around the world. In July 2017, TOMTEC became a part of the Philips Ultrasound Business group. However, TOMTEC is continuing its vendor independent product portfolio.

In this role, you have the opportunity,

As part of our Quality and Regulatory Team at TOMTEC, you will expand your knowledge and gain practical experience in the field of Quality Management & Regulatory Affairs. You will work together with international colleagues.

You will be responsible for the following topics

Your tasks will include administrative support for the team (e.g. creation and maintenance of lists, templates and forms as well as document maintenance).

To be successful in this position, you need the following knowledge and experience 

• Ongoing studies in a technical/scientific or economic field
• Pleasure in structured procedures
• Very good communication skills and distinctive team player characteristics
• Excellent knowledge of German and English (written and oral)

What we offer you

• Work in a motivated team
• Versatile, challenging tasks in an expanding company in an international environment
• An innovative environment in which you can develop further
• An excellent working atmosphere with flat hierarchies and short decision-making processes
• Flexible working hours, sports, regular team events and much more

We are looking forward to your application!

Please apply with the following documents:

• Curriculum vitae
• matriculation certificate
• testimonies

Contact
Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/en-US/jobs-and-careers/job/Unterschleissheim/Werkstudententtigkeit--m-w-d--im-Bereich-Quality-Management---Regulatory-Affairs-bei-TOMTEC_317414

Job Description

TOMTEC IMAGING SYSTEMS GMBH is an international technology leader for software solutions in the field of medical image processing and medical information management. Since July 2017, TOMTEC has been part of the Philips Ultrasound Group, but continues its manufacturer-independent product portfolio.

More than 25 years ago we started to set standards in the development of 4D ultrasound diagnostics. Our many years of experience make us the preferred partner for hospitals and companies in the healthcare IT industry. The leading manufacturers of ultrasound equipment rely on our technological expertise. More than 100 employees continuously develop, test and optimize our applications at our headquarters in Unterschleißheim/Munich and at our location in Fulda. We serve the American market through our US subsidiary TOMTEC CORPORATION.

In this position you have the opportunity,

to work together with our partners in a very international customer environment to promote future cooperation and the associated further development of our software solutions.

You will be responsible for the following topics

• Coordination, maintenance and strategic development of existing B2B sales channels and key accounts
• Acquisition and development of new cooperation partners, especially in the field of enterprise imaging and web-based image distribution
• Ongoing market observation to optimize the sales channels of the area of articipation in product portfolio planning with the goal of sustainably increasing sales and profits
• Preparation of project calculations and quotations, as well as participation in the preparation of cooperation agreements
• Support of the sales department in technical questions
• Representation of TOMTEC at trade fairs and congresses

You are part of

our currently four-person Key Account Management Team and work closely with colleagues in the development department. In this role you report to the Sr. Manager Key Accounts. 

To be successful in this position, you need the following knowledge and experience

• Successfully completed technical studies, preferably in the field of medical technology/medical information technology or comparable
• First professional experience in the B2B and/or B2C sector, ideally in the Healthcare IT sector
• Experience with cloud-based solutions and related business models (PaaS, SaaS) desired
• Strong customer orientation, strong communication and presentation skills, as well as solution-oriented and strategic thinking
• Knowledge of software engineering, project or product management would be an advantage
• Team player characteristics and high reliability
• Very good knowledge of German and English, written and spoken 

Therefore we offer you 

• Work in a motivated team
• Versatile, challenging tasks in an expanding company in an international environment
• An innovative environment in which you can develop further
• An excellent working atmosphere with flat hierarchies and short decision-making processes
• An attractive, dynamic salary model, exemplary social benefits and supplementary pension provision
• Flexible working hours, massage, sports, regular team events and much more

Contact
Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/jobs-and-careers/job/Unterschleissheim/Key-Account-Manager--m-w-d--mit-Fokus-auf-das-Partnergeschft-fr-klinische-IT-Lsungen-von-TOMTEC_315482

Job Description

TOMTEC IMAGING SYSTEMS GMBH, with headquarter located in Munich / Germany, is a worldwide leader for medical image software solutions. Specialized in cardiology it offers state-of-the-art solutions for clinical customers and industry partners. The products encompass a wide range of 2D and 3D/4D technology for visualization, automated analysis, quantification, reporting and image management. TOMTEC products are available for adult and pediatric cardiology, obstetrics, gynecology, radiology and vascular diagnostics. Moreover, TOMTEC offers a sustainable full-service component in sales and an education program with best-practice sharing among professionals. The company claim "Excellence in Digital Healthcare" represents striving for excellent image and analysis quality, ease-of-use, reproducibility of automated measurements and an all-around service- and education offering. The company maintains close working relationships with many leading universities and research institutes around the world. In July 2017, TOMTEC became a part of the Philips Ultrasound Business group.  However, TOMTEC is continuing its vendor independent product portfolio.

In this role, you have the opportunity to

Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission. 

You will manage a team of 2 regulatory subject matter experts supporting various new and sustaining programs and will work closely with the regulatory team members, most of which are located in the US territory. Additionally you will be responsible for providing direct support to business critical New Product Introduction projects and maintaining the lifecycle of regulatory processes that are relevant to meet state of the art requirements.

You are responsible for

• Leading the team of regulatory professionals responsible for establishing and executing innovative regulatory strategies;
• Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained;
• Reviewing and recommending changes for design control processes and manufacturing procedures to maintain quality and regulatory compliance;
• Providing guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally;
• Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements are determined to go into effect;
• Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols;
• Advising on regulatory policy (for market release) in line with TOMTEC and Philips regulatory policy;
• Where applicable, represent TOMTEC in an international committee chartered to develop an applicable standard as well as in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body;

You are a part of

You are a part of the local TOMTEC team in Unterschleißheim and the Philips Ultrasound Regulatory Affairs Organization with a global footprint. You will report to the Head of Regulatory Affairs for Business Group Philips Ultrasound. The Regulatory Affairs team is multicultural and consists of enthusiastic professionals that work as a team to ensure regulatory compliance.

To succeed in this role, you should have the following skills and experience

• Bachelor/Master of Science degree in a technical or business discipline;
• Minimum of 8 years of relevant experiences
• Management experience is preferred;
• First line experience with US FDA and EU MDD, , China NMPA preferred;
• Understands the requirements surrounding EU MDR requirements;
• Maintains detailed knowledge on the subject of ISO 13485 and QSR requirements;
• Experiences surrounding international regulatory submissions and registrations;
• Experience with successful preparation and submission of Technical Documentation, 510(k), PMA, and registrations of medical devices globally;
• Experience with Software as Medical Devices, Ultrasound Imaging Devices is preferred;
• Team player who can work in a matrixed environment with teams in different locations;
• 5-10% of travel may be required;

In return, we offer

• Working in a motivated team
• Versatile, challenging tasks in a growing company in an international environment
• An innovative environment with the chance to evolve
• An excellent working atmosphere with flat hierarchies and short decision makings
• An attractive and dynamic- salary package, excellent employee benefits and supplementary pension
• Flexible trust-based working hours, massages, sports courses, regular team events and much more

Contact
Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/de-DE/jobs-and-careers/job/Munich/Manager-Regulatory-Affairs--m-w-d-_320173

Job Description

TOMTEC IMAGING SYSTEMS GMBH, with headquarter located in Munich / Germany, is a worldwide leader for medical image software solutions. Specialized in cardiology it offers state-of-the-art solutions for clinical customers and industry partners. The products encompass a wide range of 2D and 3D/4D technology for visualization, automated analysis, quantification, reporting and image management. TOMTEC products are available for adult and pediatric cardiology, obstetrics, gynecology, radiology and vascular diagnostics. Moreover, TOMTEC offers a sustainable full-service component in sales and an education program with best-practice sharing among professionals. The company claim "Excellence in Digital Healthcare" represents striving for excellent image and analysis quality, ease-of-use, reproducibility of automated measurements and an all-around service- and education offering. The company maintains close working relationships with many leading universities and research institutes around the world. In July 2017, TOMTEC became a part of the Philips Ultrasound Business group.  However, TOMTEC is continuing its vendor independent product portfolio.

In this role, you have the opportunity to

make product releases successful and to maintain the product portfolio throughout the different versions in the market. You will collaborate closely with the software development team and are responsible for software of unknown provenance as well as post market surveillance.

You are responsible for

• Manage upcoming releases by identification of variant, deployment and licensing needs
• Part of quality gate to assess impact of changes on upcoming release
• Decide on branching strategy for upcoming releases.
• Identify and address technical risks for upcoming releases
• Control active versions in the market and provide infrastructure for building them
• Responsible for completion and configuration of all product deliverables with in the device master record (continuous integration environment)
• Own processes related to third party SW management and coordinate the respective post market surveillance activities
• Trigger product version termination
• Cooperate on the technical implementation with the product security officer and the IT tools specialist
• Responsible to moderate, decide on and document best practices for technical release management and the respective ways of working in an agile environment
• Cooperate with project management to get a successful release in the market

You are part of

the competence unit clinical products which is responsible to enable for efficient, transparent and regulatory compliant development of a high quality product. The unit acts as an umbrella for the development department platform, clinical applications and reporting/measurements. By addressing the needs of the business unit and customer support it helps to make the product successful in the market. You will report into the Senior Manager Clinical Products.

To succeed in this role, you should have the following skills and experience

• Degree in engineering (ideally medical engineering)
• 3+ years of technical knowledge in (medical) software engineering
• Project management skills with scripting skills
• Distinct ability to work in a team, ability of getting team alignment
• Autonomous, well organized and target-oriented
• Strong communication and collaboration skills
• Language skills: Grade C in English

In return, we offer

• Working in a motivated team
• Versatile, challenging tasks in a growing company in an international environment
• An innovative environment with the chance to evolve
• An excellent working atmosphere with flat hierarchies and short decision makings
• An attractive and dynamic salary package, excellent employee benefits and supplementary pension
• Flexible trust-based working hours, massages, sports courses, regular team events and much more

Contact
Interested? Please only apply online via Philips:

https://philips.wd3.myworkdayjobs.com/jobs-and-careers/job/Unterschleissheim/Manager-Software-Releases--m-f-d--for-medical-software-at-TOMTEC-in-Munich_320158-1