Senior Director Quality, Post-Market Surveillance, Class III Medical Device | Remote (US)

Senior Director, Post-Market Surveillance & Clinical | Orthopaedic Devices | Remote (US) + North Florida Travel

Post-market isn't a back-office function here, it's where the real influence sits. You'd be walking into a team that's ready for strong, steady leadership, and a company that's genuinely invested in getting this hire right.

If you've navigated MDSAP or EU MDR, worked FDA observations, and know what it means to actually own signal tracking, trending, and complaint categorization at scale, this is worth 10 minutes of your time.

What you'd be walking into:

• 80% post-market surveillance, 20% clinical program management (PM, not clinical trial work), full ownership of CER/CP and PMS reporting
• A team that's been through a lot of change and needs steady, accountable leadership, not a taskmaster and not a friend
• A company backing an orthopaedic portfolio that's scaling fast

What makes you a fit:

• Orthopaedic device background, non-negotiable
• 7-10 years in medical devices, proven director-level leadership (not a first director seat)
• Experience with Clinical Evaluation Reports (CER/CP) and clinical program management, this isn't clinical trial experience, but you should know how to run that side of the work
• You lead with empathy as much as accountability, this team needs someone who builds trust, not someone who commands it
• Comfortable with a travel cadence: remote-based, but you'll be onsite in North Florida about 1 week every 4-5 weeks (fully covered)

If this sounds like your next seat at the table, message me or apply directly. Even a quick "tell me more" gets the conversation started.