Senior Platform Regulatory Specialist
Core
Ensures regulatory compliance and strategy alignment for medical device platform projects across global markets.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory strategies and submissions for medical device platforms
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Global medical device regulations, Quality System Standards (ISO 13485), Design Controls, project plan review, qualification protocols, regulatory data management, audit/inspection support, M&A integration
Preferred skills
RAC certification
Technologies
Modern computer skills
Responsibilities
Collaborate with stakeholders to align regulatory goals with business strategy; maintain product knowledge and organize data for global submissions; partner with Regional RA on regulatory strategy execution; represent the company with regulatory authorities; support due diligence and M&A integration; ensure compliance with evolving regulations; support audits and inspections.
Seniority
Senior, 8+ years experience