Regulatory Affairs Specialist Medical Devices EMEA (m/f/*)

Job Description :

Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you.

With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers.

The Impact You’ll Make in this Role

As a Medical Device Certification and Conformance (C&C) Specialist (m / f / *), for the Personal Safety Division (PSD), you will be responsible for providing regional C&C in the testing, certification and registration for PSD personal protective equipment (PPE) that is registered as a medical device.

Reporting to the global medical device C&C leader, this person will be responsible for :

• Medical device registration (medical respirators and future PPE) in EMEA countries including Middle East and Africa.
• Fulfilling requirements, as assigned, for roles required within applicable standards and regulations (e.g. Person Responsible for Regulatory Compliance (PRRC) and CH-Rep).
• Managing EUDAMED database
• Maintaining the compliance status of medical respirators
• Regulatory / compliance input into PSD new product projects and conduct regulatory assessments for new products during the commercialization process
• Overseeing the compliance aspect of product changes and making refiling / modification decision for changes made to existing medical respirators
• Working with cross functional groups closely to ensure the registration files quality and on-time completion
• Actively working with external parties such as testing lab, government agencies, notified bodies, and third party agencies to accelerate the registration processes
• Monitoring and understanding registration related regulations across EMEA and taking actions accordingly
• Engaging with regulatory authorities with any post-market issues

Your Skills and Expertise

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications :

• Bachelor’s degree or higher majoring in material, engineering, biotechnology, pharmacy, or related fields
• Strong proficiency in both English and German
• Fundamental working experience as regulatory affairs in medical device area
• Working experience in multinational companies.

Additional qualifications that could help you succeed even further in this role include :

• Strong interpersonal skills and able to build internal and external networks
• Self-starter who can effectively work in a fast-paced environment, with an appropriate sense of urgency
• Experience working within QMS (ISO 13485 and ISO14971) is desirable

Supporting Your Well-being

3M offers many programs to help you live your best life both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.

Resources for You

For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at If you have further questions please reach out to Max (our AI Virtual Assistant) via our Career Page.

Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals.

Our global Work Your Way initiative gives our employees flexibility in where and how their work can be performed, subject at all times to any location-specific rules and policies that may be in place from time to time (more information on such rules / policies can be provided upon request from the relevant in-location HR).

At 3M, we believe diversity & inclusion are essential to innovation. We seek and value differences in people! This Job ad is addressed to all potential candidates.

As an equal opportunity employer 3M will not discriminate against any applicant for employment on the basis of race / ethnicity, nationality, religion, sex, gender identity, sexual orientation, pregnancy / maternity-related matters, age or disability, or any other relevant characteristic protected under applicable local law.