Job Details

A growing medical device company developing Class III Medical Devices is seeking a Senior Director of Regulatory Affairs to lead strategy and execution across the US.

This is a hands-on leadership role, ideal for someone with deep regulatory knowledge in the US and a passion for mentorship, cross-functional collaboration, and innovation in a fast-paced, mission-driven environment.

What You'll Be Doing:

• Lead a talented regulatory team in developing and executing submission strategies (PMA, IDE, etc.) for class III medical devices.
• Own regulatory planning and agency interactions (FDA, Notified Bodies, international authorities).
• Collaborate across R&D, clinical, quality, and marketing to ensure global compliance.
• Support audits, inspections, and implement proactive risk mitigation strategies.
• Manage regulatory compliance function and product-focused RA team.
• Influence the broader business by aligning regulatory activities with commercial priorities.

Who We're Looking For:

• 10+ years in regulatory affairs, ideally with some Class III implantable devices.
• Strong working knowledge of U.S. FDA and regulatory submissions.
• Experience with PMA/IDE submissions.
• Proven team leader and strategic thinker.
• Excellent communication skills, comfortable engaging with executives and regulators alike.

This is a fantastic opportunity to be a key regulatory leader within a growing organization that's genuinely improving lives.

Base pay range

$220,000.00/yr - $260,000.00/yr

Seniority level

Senior

Employment type

Full-time

Job function

Quality Assurance and Legal

Equal Employment Opportunity

We are an equal opportunities employer and welcome applications from all qualified candidates.