Regulatory Affairs Manager

Ready to make a real impact in the medical implant field?

We’re looking for a Regulatory Affairs Manager to lead international compliance and registration strategies, ensuring smooth market access for our innovative Class III medical devices. If you're proactive, detail-oriented, and passionate about turning complex regulations into opportunity, this is your chance to shape the future of healthcare.

Role Incentives

• 30 days of vacation
• Hybrid and flexible working options
• Company pension plan & monthly givve® Card
• Access to exclusive employee discounts (Corporate Benefits)
• Structured onboarding and development opportunities
• Recognition bonuses for birthdays and anniversaries
• Supportive, agile culture with flat hierarchies
• Fun team events in summer and winter

Key Responsibilities

• Manage and maintain international product registrations and approvals for Class III medical devices.
• Prepare, update, and review comprehensive technical documentation in alignment with applicable regulatory requirements.
• Monitor global regulatory changes and perform gap analyses to ensure continued compliance with international standards and regulations.
• Review and validate user manuals, labels, and other customer-facing documentation to ensure regulatory conformity.
• Collaborate cross-functionally with R&D, Quality Assurance, Production, and external partners to support product development and lifecycle management.
• Serve as the point of contact for regulatory authorities and customers regarding regulatory matters.
• Design and deliver internal training sessions to ensure teams are up to date on regulatory requirements and changes.

Your Profile

• University degree in a scientific discipline, biomedical engineering, or a related field.
• Minimum of 5 years of experience in regulatory affairs within the medical device industry, preferably with Class III products.
• Strong knowledge of relevant standards and regulations (e.g., EN ISO 13485, EU MDR, 21 CFR).
• Certified as an International Regulatory Affairs Manager.
• Proven experience with EU and FDA submissions and approvals.
• Auditor certification is a strong advantage.
• High proficiency in MS Office and digital tools.
• Excellent written and verbal communication skills in English and German.

Who Are Adaptive Life Science?

Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.

We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.

Why Apply With Us?

Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:

• Expert advice on your CV and cover letter
• Guidance on salary expectations
• Personalized interview preparation
• Connections to exclusive job opportunities
• Assistance in negotiating the best possible offers
• 50% of the CVs we send to clients are accepted
• Accepted or declined, either way we will provide you with feedback

We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.

Who Do Adaptive Work With?

We offer a wide portfolio of over 150 Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.

If you are interested in this role, please apply with your CV or contact Alisa Liddell for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.

alisa.liddell@adaptivelifescience.com

49 30 16638376