Regulatory Affairs Thought Leader – Medical Device Consulting

Company Description

Eurofins is the world leader in the bio/pharmaceutical testing market. With over €6.95 billion in annual revenues and 63,000 employees across 950 sites in 60 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the biopharmaceutical, food, and environmental industries. The Eurofins BioPharma Product Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world’s largest pharmaceutical and biopharmaceutical companies. The service portfolio supports all stages of the drug development process and all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control.

Job Description

Eurofins Medical Device Consulting is seeking an experienced and influential Regulatory Affairs Thought Leader to serve as a strategic partner to our marketing and sales teams and a visible representative of our brand in the marketplace. This individual will elevate our presence at trade shows and conferences, contribute to the definition and promotion of consulting service offerings, and help shape our voice as a leader in medical device regulatory strategy. The ideal candidate is a seasoned regulatory professional—preferably with former FDA experience—who is comfortable in both technical and commercial environments, and who excels at communicating regulatory strategy in a client-facing, high-impact way. Key Responsibilities: External Thought Leadership & Brand Representation

• 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. Marketing and Service Development Support
• 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. Sales and Business Development Enablement
• 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. Internal Collaboration and Innovation
• 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.

Qualifications

• 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. Additional Information

The position is full-time, Monday-Friday, 8:00 a.m.- 5:00 p.m., with overtime as needed.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

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