Regulatory Affairs Specialist – US Market Focus

We’re looking for a motivated and detail-oriented Regulatory Affairs Specialist to join a dynamic team in the medical technology sector. This role is key to securing regulatory approval for both new and existing products in the US market, supporting their compliant and timely launch.

Responsibilities include coordinating regulatory strategies, preparing and submitting filings, and maintaining up-to-date regulatory and product databases. The position also involves supporting the US Agent and Official Correspondent, and closely monitoring regulatory developments to ensure continued compliance.

This is a great opportunity to contribute to meaningful projects in a collaborative, fast-paced environment where your expertise will directly impact product success and patient safety.

Key Responsibilities

• Manage the regulatory approval process for new and existing products in the US
• Strategic planning and coordination of regulatory approvals, as well as the preparation and submission of regulatory filings
• Prepare and submit regulatory filings via eStar, including 510(k) submissions
• Maintain regulatory and product databases to ensure compliance
• Support UDI management for accurate product labeling and identification
• Monitor regulatory developments and implement legal requirements in collaboration with specialist departments

Required Qualifications and Skills

• Degree in engineering, natural sciences, human medicine, medical technology, or life science
• Initial professional experience in regulatory affairs/approval is advantageous
• Proactive approach with a focus on efficient solutions
• Strong communication skills with a collaborative mindset
• Very good written and spoken German and English skills

Benefits and Perks

• Varied tasks with opportunities to shape future-relevant projects
• Modern working environment with openness to new technologies
• Attractive salary package including Christmas and vacation pay, voluntary performance bonus, and distance-dependent travel allowance
• Flexible working hours and remote work options by arrangement
• Comprehensive health and sports activities: ergonomic workstations, company sports, Hansefit membership, health days, company doctor, and free vaccinations
• Seasonal and delicious food, freshly prepared by our kitchen team
• Complimentary drinks and fresh fruit available daily
• Flat hierarchies and short decision-making paths promoting independent work
• Structured onboarding process for a successful start
• Regular company events to foster team spirit and collaboration
• Continuous professional development through tailored training and learning opportunities
• Employee discounts on top brands via Corporate Benefits platform

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

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.