Quality and Regulatory Affairs Specialist (Medical Devices)

Join a well-established medical device company specializing in complementary medicine and ozone therapy. The company develops and supplies high-quality ozone therapy devices and consumables internationally and is expanding into new markets, including the US.

As Quality and Regulatory Affairs Specialist, you will lead global regulatory compliance, manage certifications, and support international growth

Key Responsibilities

• Lead quality and regulatory systems (ISO 13485, MDR compliance)
• Manage audits by Notified Bodies and authorities
• Maintain and expand technical documentation
• Conduct supplier and internal audits
• Support international product registrations and FDA market entry
• Collaborate with QA, R&D, Production teams
• Manage and mentor junior RA staff

Requirements

• Proven Regulatory Affairs experience in medical devices (Class IIb/I)
• Strong knowledge of ISO 13485 and EU MDR (2017/745)
• Experience with Notified Bodies and technical documentation
• Fluent English; German B1 or higher preferred
• Project management and communication skills
• FDA registration experience is a plus

Reach out to Alisa Liddell for more information about the company culture, and long-term development plans

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

DE Tel: +49 30 16638376