Senior Regulatory Affairs Program Specialist
Core
Leading cross-functional collaboration to ensure regulatory compliance for medical devices used in cardiopulmonary and respiratory care.
Role type
Senior Regulatory Affairs Program Specialist
Builds
Global market entry for AEDs, ventilators, and trauma kits
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Medical device regulatory compliance, FDA interaction, risk management planning, change control, standards strategy, technical writing, project management
Preferred skills
Engineering concepts, scientific terminology, manufacturing processes
Technologies
None stated
Responsibilities
Evaluate and resolve regulatory and technical issues, lead technical medical device compliance initiatives, review global regulatory submissions, initiate reviews of change requests and regulatory strategies, collaborate with R&D on risk management plans, participate in regulatory audits/inspections, author and maintain SOPs
Seniority
Senior, hands-on IC