Full-Time Regulatory Affairs Thought Leader

• Represent Eurofins Medical Device Consulting at trade shows, conferences, and client-facing events.
• Deliver compelling presentations, moderate panels, and contribute to discussions on key regulatory trends, challenges, and solutions.
• Serve as a strategic regulatory voice for the company in public forums and publications.

• Partner with marketing to define, refine, and promote consulting service offerings (e.g., packaging, sterilization, microbiology, biocompatibility, combination products).
• Translate regulatory trends into marketing content, white papers, blog posts, and educational tools.
• Help shape value propositions and messaging for service packages that meet real client needs.

• Support the sales team in strategic client engagements, particularly with complex or high-value opportunities.
• Join key sales meetings to offer regulatory insight and build client confidence.
• Help develop proposal content, pitch decks, and regulatory positioning that aligns with client pain points.

• Provide input on emerging regulatory topics and client demands that should inform future services and capabilities.
• Collaborate with technical SMEs, consultants, and the marketing team to ensure alignment across messaging, delivery, and expertise.
• Mentor and guide junior consultants on regulatory approaches and industry best practices.

• Advanced degree in Regulatory Affairs, Biomedical Engineering, Law, Pharmacy, or a related scientific discipline.
• Former FDA experience strongly preferred; experience with other global regulatory bodies (e.g., EMA, MHRA, Health Canada, PMDA, NMPA) is a plus.
• 10+ years of experience in regulatory affairs for medical devices, IVDs, or combination products.
• Previous experience in a consulting, CRO, or client-facing role is preferred.
• Deep working knowledge of FDA regulations, EU MDR/IVDR, ISO standards (e.g., 10993, 11607, 11135/11137, 11737), and current industry trends.
• Ability to clearly and confidently communicate regulatory requirements in presentations, writing, and dialogue with both technical and non-technical stakeholders.
• Proven track record of public speaking, authorship, or other industry thought leadership activities.
• Willingness to travel (20–30%) to conferences, trade shows, and key customer events.

What is the last date for applying to the job?

Which countries are accepted for this remote job?