Job Title

Regulatory Affairs Specialist (m/w/d) medizinische Software
 

Job Description

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.

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.     

In dieser Position haben Sie die Möglichkeit,

die Verantwortung für die regulatorische Konformität der sehr innovativen TOMTEC-Produkte (stand-alone Software, AI) und für die Entwicklung und Umsetzung wettbewerbsfähiger regulatorischer Strategien zu übernehmen. Sie arbeiten mit Regulierungsbehörden zusammen, um bestmögliche Ergebnisse für effektive Produkt-Marktfreigaben zu erzielen. Außerdem stellen Sie die Koordination und Vorbereitung von Dokumentenpaketen für Zulassungsanträge (z.B. FDA, Health Canada) sicher und empfehlen Strategien für klinische Bewertungen.
 

• Für folgende Themen bekommen Sie die Verantwortung
• Unterstützung bei regulatorischen Fragen wie Kennzeichnung und Marketingideen
• Vorbereitung von regulatorischen Dokumenten im Entwicklungsprozess
• Empfehlung von Strategien für effiziente und effektive Produktzulassungen bzw. Ermitteln des Marktzuganges
• Regulatorische Unterstützung der Teams in allen Phasen des Produktentwicklungsprozesses für neue Produkte oder bei Produktänderungen
• Ermitteln der Länderanforderungen und Weitergabe an die entsprechenden Abteilungen
• Direkte Verantwortung für die Koordination und Vorbereitung von Dokumentenpaketen für Zulassungsanträge weltweit und die Durchführung der Zulassung bzw. des Marktzuganges (regulatorisch)
• Anleitung zur Einhaltung der Produktkonformität weltweit, wie z. B. CE-Kennzeichnung
• Aufrechterhalten der Registrierungen
• Schulungen zu regulatorischen Anforderungen

Sie sind Teil von

unserem Regulatory Affairs Team bei TOMTEC und berichten an den Manager Regulatory Affairs. 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 3 Jahre Berufserfahrung in einer vergleichbaren Position, insbesondere Erfahrungen in Hinblick auf Software als Medizinprodukt von Vorteil
• Fundiertes Wissen über Medizinproduktevorschriften und AI von Vorteil
• Kenntnisse in Hinblick auf 510k und EU-MDR gewünscht
• Kenntnisse im Normenmanagement sowie Wechsel einer benannten Stelle von Vorteil
• Eigenverantwortliche und analytische Arbeitsweise
• Gute Kommunikationsfähigkeit und ausgeprägte Teamplayereigenschaften
• Lösungsorientierung und Offenheit für neue Ideen
• Hervorragende Englisch- und gute Deutschkenntnisse (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
• Ein attraktives, dynamisches Gehaltsmodell, vorbildliche Sozialleistungen und eine zusätzliche Altersversorgung
• Flexible Vertrauensarbeitszeit, Massage, Sportangebote, regelmäßige Team-Events und vieles mehr

Warum sollten Sie zu uns kommen?

Das Arbeiten bei Philips ist mehr als nur ein Job. Es geht darum, durch unsere Arbeit dazu beizutragen, eine gesündere Gesellschaft zu schaffen und durch innovative Lösungen über das gesamte Health Continuum die Lebensqualität von 3 Milliarden Menschen zu verbessern. Unsere Mitarbeiter erleben eine Vielzahl von Momenten, in denen ihr Leben und ihre berufliche Tätigkeit auf sinnvolle Weise miteinander verschmelzen.

Um mehr über das Arbeiten bei Philips zu erfahren, besuchen Sie „Philips als Arbeitgeber“ auf unserer Karriere-Website, wo Sie in unserem Mitarbeiter-Blog Berichte über den Arbeitsalltag bei Philips lesen können. Hier erfahren Sie auch mehr über unser Einstellungsverfahren und finden Antworten auf einige häufig gestellte Fragen.

Philips ermuntert Menschen mit Behinderung, sich bei uns zu bewerben.
 

Full applications  are welcome via Philips 

Job Title

Manager Regulatory Affairs (m/w/d)

Job Description

In this role, you have the opportunity to

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 two regulatory subject matter experts supporting various new and sustaining programs for the TomTec business of Philips Ultrasound. Moreover, you will be responsible for providing needed direct support to business critical New Product Introduction projects and maintaining 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 for New and Sustaining Philips Ultrasound/TomTec portfolio

• 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 EU MDR, 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 Philips regulatory policy;

• Representing Philips Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body

• Manage, mentor and coach Philips Ultrasound regulatory professionals in their development

You are a part of

the Philips Ultrasound Regulatory Affairs Organization with a global footprint. You will report to 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 10 years of experience in a similar role

• Management experience is required

• First line experience with US FDA and EU MDD/MDR

• Detailed knowledge on the subject of ISO 13485 and QSR requirements

• Experiences surrounding international regulatory submissions and registrations

• Must have experience with successful preparation and submission of Technical Documentation, 510(k)

• Experience with Software as Medical Devices, and Ultrasound Imaging Devices is preferred

• Teamplayer who can work in a matrixed environment with teams in different locations

•    5-10% of travel may be required
   

In return, we offer you

to grow your career in a company with a unique purpose to make the world healthier and more sustainable through innovation. You can join an innovative health-tech company that values the interaction between technology and people, working in a multinational and multicultural environment. You will be surrounded by diverse colleagues who share your passion to create superior consumer experiences. Your work will be challenging and full of opportunities for growth. Variety and challenge will be part of your daily routine.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

As an equal opportunity employer, Philips is committed to a diverse workforce. You will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

Full applications  are welcome via Philips 

Job Title

Product Manager (m/f/d) Clinical Imaging Software Cardiovascular

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.

 

In this role, you have the opportunity to

directly influence the future of our products. You are the interface between our customers and the development department and transfer customer needs into requirements.   By doing so, you are in touch with KOLs and support them along the way to develop our newest innovations in the cardiovascular field.

You are responsible for

• Responsibility for upstream marketing activities for the lifecycle and professional services / products / solutions, including definition of the strategy and its enablers as well as its alignment with key markets globally

• Value proposition development based on customer insights, including Health Economics for lead markets

• Pricing (Price setting) and margin optimization as well as Channel Strategy for assigned portfolio

• Compliance with Quality & Regulatory requirements (if applicable)

• Drive definition, development and introduction of the products/solutions/ lifecycle and professional services, including cross-business solution development to our customers by meeting their needs

• Responsible for lifecycle management and market readiness

• P&L responsible for Product, software, lifecycle and professional services and/or Solutions development

• Analyzing the market, the competition, and trends on enterprise level across segment technologies

• Translate in-depth market and customer insights, as well as competitive analyses into winning concepts/ clear lifecycle and professional services, software or product specifications

• Guide and drive the development of new products, lifecycle and professional services, software or solution from the initial phase until the final product

You are part of

the Ultrasound Sales, Marketing and Services team which is characterized by close collaboration and team spirit. In this role you report into the Business Development Management Lead Ultrasound.
 

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

• University degree or Medical technical assistant education, professional experience in similar position preferred

• Minimum of 3 years professional experience

• Knowledge of clinical settings and workflows in the cardiovascular field

• Good technical skills and ability to interact with engineering staff (Software Engineering) on details as well as with sales/ customers/ partner companies on product benefits and clinical workflows

• Excellent communication and presentation skills

• Proactive and organized way of working

• Ability to lead, manage and motivate cross-functional teams

• Fluent English skills (written and oral), 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

• 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

Why should you join Philips? 

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2,5 billion lives a year by delivering innovative solutions across the health continuum.  

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions. 

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status. 

Full applications  are welcome via Philips