Principal Quality and Regulatory Affairs Specialist (f/m/d) Healthcare/Ultrasound

TomTec Imaging Systems GmbH; Unterschleißheim; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Ein international führendes Unternehmen in der medizinischen Bildgebung sucht einen Principal Quality and Regulatory Affairs Specialist, um regulatorische Strategien zu entwickeln und die Konformität von Ultraschallprodukten sicherzustellen. Erforderlich sind mindestens 7 Jahre Erfahrung im Gesundheitswesen und ein Bachelor-Abschluss in einem relevanten Fach. Wir bieten ein vollzeitbeschäftigung in einem motivierten Team mit flexiblen Arbeitszeiten und Entwicklungs opportunities.

Leistungen

Flexible Arbeitszeiten

Wohlfühlprogramme

Zusätzliche Familien- und Gesundheitsunterstützungsdienste

Wettbewerbsfähiges Gehalt und Sozialleistungen

Mitarbeiterevents

Qualifikationen

• Mindestens 7 Jahre Erfahrung in FDA-regulierten Medizinprodukten oder Gesundheitstechnologie.
• Erfahrung mit US FDA, China NMPA, EU MDR, ISO 13485.
• Kenntnisse zu SaMD und bildgebenden Geräten sind von Vorteil.

Aufgaben

• Leitung von Produktentwicklungsprojekten für AI SaMD und Überwachung der Einhaltung.
• Entwicklung von regulatorischen Strategien und Risikobewertung.
• Vertretung während Audits und Inspektionen.

Kenntnisse

Regulatory Compliance

Projektmanagement

Verhandlungsführung

Risikobewertung

Teamarbeit

Englisch

Deutsch

Ausbildung

Bachelor-Abschluss in einem technischen, qualitativen, regulatorischen oder geschäftlichen Fachbereich

Jobbeschreibung

TOMTEC IMAGING SYSTEMS GMBH has been an international technology leader in medical imaging and information management software solutions for 30 years.

Our product portfolio includes innovative diagnostic and analysis applications in cardiology, radiology, gynecology, and obstetrics.

We pioneered 4D ultrasound diagnostics, providing expectant parents with three-dimensional images of their unborn child. With over 170 staff worldwide, we collaborate with hospitals and healthcare IT companies, integrating our software into their products.

Our headquarters in Unterschleissheim near Munich focus on the development, testing, and optimization of our applications. Through our US subsidiary, TOMTEC Corporation, we distribute products and support customers in the US.

Our goal is to be the global leader in medical imaging and information processing. We offer state-of-the-art workstations and a diverse range of employee benefits, recognized by awards such as "Great Place to Work" in 2019.

Employee benefits include:

• Health care services like massages
• Sports activities including yoga and back training
• Leisure amenities such as table football and a beer garden
• Free drinks and an in-house muesli bar
• Canteen allowances or meal vouchers
• Options for a company bicycle, company car, and cycle storage
• Company pension schemes and investment contributions
• Various sporting events, an annual kids' day, and a family summer celebration

*Benefits may vary by region.

We value a healthy work-life balance, offering flexible working hours, vacation arrangements, and work-from-home options.

WIE ES WEITERGEHT

We are always seeking qualified staff to support our growth and uphold our quality standards. We look forward to your application.

NEXT STEPS

If you're interested in working with us, please send your complete application documents via email—this saves time and costs associated with mailing.

We request an application including:

• A letter resume in table format
• Relevant certificates (highest educational qualification, up to 2 employer references)
• Desired start date and salary expectations

We will review your application promptly and invite suitable candidates for interviews and work trials. Your application will be handled confidentially. For questions about the process, contact us.

Position: Principal Quality and Regulatory Affairs Specialist (f/m/d) Healthcare/Ultrasound

Job Description

In this role, you will contribute to developing and deploying regulatory strategies for ultrasound products, ensuring compliance and market access.

Responsibilities include:

• Leading product development projects for AI SaMD and overseeing lifecycle compliance
• Developing and communicating regulatory strategies, assessing risks, and proposing mitigation measures
• Negotiating with regulatory agencies and managing filings
• Providing guidance on global compliance standards, including CE marking, FDA, NMPA, EU MDR, ISO standards, and others
• Updating procedures to reflect regulatory changes
• Supporting clinical studies and regulatory submissions
• Representing the organization during audits and inspections
• Improving regulatory aspects of the Quality Management System

Qualifications:

• Bachelor’s degree in a Technical, Quality, Regulatory, or Business discipline
• At least 7 years’ experience in FDA-regulated medical devices or health-tech environments
• Experience with US FDA, China NMPA, EU MDR, ISO 13485, and successful submission of medical device documentation
• Knowledge of SaMD and imaging devices is highly preferred
• Ability to work in a matrix environment with international teams
• Proficiency in English; German skills are a plus

We offer:

• Stable, full-time employment in a motivated team
• Challenging tasks in an expanding company
• Opportunities for professional development
• Competitive salary, social benefits, and pension scheme
• Flexible hours, wellness programs, and team events
• Additional family and health support services

Philips is an equal opportunity employer. All qualified applicants will be considered regardless of race, religion, gender, or other protected characteristics.

Applications should be submitted via Philips.