What You'll Do
Drive regulatory and commercial success for medical device clients targeting the U.S. market. You will own the development and expansion of a client portfolio, identifying new opportunities and converting them into long-term engagements that support sustained revenue growth.
Provide senior-level strategic counsel on FDA regulatory pathways—including 510(k), De Novo, PMA, and IDE—ensuring clients understand the most efficient routes to market. Lead pre-submission planning, clinical integration strategies, and lifecycle management, aligning regulatory requirements with business goals.
Represent the organization as a recognized expert in the U.S. MedTech space. Lead high-stakes interactions with the FDA, including Pre-Sub meetings, IDE discussions, and PMA panel preparations. Prepare and review critical regulatory submissions, ensuring clarity, compliance, and strategic alignment.
Translate complex regulatory expectations into practical business guidance, serving as a trusted advisor to executive teams. Build visibility through industry events, conferences, and client-facing engagements, strengthening the firm’s presence in the U.S. ecosystem.
Requirements
- Hold a bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline.
- Bring over a decade of experience in medical device regulatory affairs, gained in industry, consulting, or a combination of both.
- Demonstrate in-depth knowledge of U.S. regulatory frameworks, including FDA submission types and review processes.
- Have a proven track record of direct engagement with the FDA, including briefing package development and meeting leadership.
- Show the ability to build and grow a professional network across the U.S. MedTech sector.
- Combine technical expertise with a commercial mindset, contributing directly to business development and client retention.
- Communicate effectively with senior stakeholders, influencing decisions through clear, strategic insights.
- Operate independently while collaborating across global teams in a consulting environment.
- Be available for travel within the U.S. and internationally to support client needs and business growth.
Preferred Qualifications
Experience navigating international medical device regulations in parallel with U.S. requirements is a strong advantage, particularly for clients pursuing global market strategies.
