Principal Regulatory Affairs Project Manager, Medical Devices
West
Exton, PA, US
On-site
Lead regulatory strategies and execution
Manage complex regulatory programs
Drive global regulatory compliance
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week
Job Summary
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.
The Principal Regulatory Affairs Project Manager is responsible for leading complex, high‑visibility regulatory programs across West’s portfolio of medical devices, combination products, and packaging/containment systems.
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century.
Matching Summary
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.
Skills & Requirements
Must-have
Lead regulatory strategies and execution
Manage complex regulatory programs
Drive global regulatory compliance
Prepare and submit regulatory dossiers
Manage regulatory risks and issues
Collaborate with cross-functional teams
Nice-to-have
Continuous improvement initiatives
Optimize RA databases
Lifelong learning and growth opportunities
Key Requirements
Bachelor's degree with 5+ years experience or Master's degree with 3+ years experience
Experience in medical devices and combination products