Regulatory Affairs Thought Leader - Medical Device Consulting
Regulatory Affairs Thought Leader - Medical Device Consulting
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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 professionalpreferably with former FDA experiencewho 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. 11135/) 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 (2030%) 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
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
