Staff Regulatory Affairs Specialist

We are seeking an accomplished Staff Regulatory Affairs Specialist to serve as a senior individual contributor and subject matter expert within our growing Regulatory Affairs organization. This is a strategic, high-visibility role for a seasoned regulatory professional who can independently drive complex U.S. and international submissions, shape regulatory strategy across the product portfolio, and mentor junior team members.

What You Will Do

In this role, you will lead the strategy, preparation, submission, and negotiation of complex U.S. and international regulatory filings, drive the development and continuous improvement of scalable regulatory infrastructure, and act as a primary liaison with FDA and global regulatory bodies.

Why It Might Be a Fit

The ideal candidate brings deep FDA expertise, advanced command of global regulatory landscapes, and a proactive, collaborative mindset to navigating complex, evolving regulatory environments. You will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization.

Requirements

• Master's degree with a minimum of 8 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 10 years of directly relevant regulatory affairs experience
• Extensive prior experience interfacing with the FDA and/or other regulatory agencies
• Proven success independently leading multiple FDA submissions
• Recognized subject matter expertise in providing regulatory guidance for biocompatibility, packaging, sterilization, software, electrical safety and EMC, labeling, and reviewing and approving product claims and promotional content
• Advanced understanding of U.S. regulatory requirements; working knowledge of EU MDR and other international regulations
• Demonstrated ability to lead and influence cross-functional teams
• Strong analytical capabilities, deep understanding of design controls, manufacturing, change control, and awareness of regulatory industry trends
• Experience with medical device eQMS is required
• Proven mentor and coach — able to develop junior regulatory talent and elevate team capability through knowledge sharing and structured review

Benefits

• Competitive salary of $160,000 - $175,000
• Variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• 401(k) plan
• Healthcare insurance
• Paid vacation
• Compliance with relevant county, state, and Federal rules regarding vaccinations