Job Description
Senior Director of Regulatory Affairs
Hybrid working - some travel to Bay Area
Medical Devices – Class III
Competitive compensation + strong benefits
A growing medical device company developing Class III Medical Devices are 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-focussed 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.
Apply today for a call back to discuss - this position will move to interview and offer in mid-October!