Director of Regulatory Affairs

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.

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