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 .

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TomTec Imaging Systems GmbH

Jobs:

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

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