Senior Regulatory Affairs Specialist - Onsite
Core
Develop strategies for worldwide product registration and prepare regulatory submissions for medical devices to introduce products and changes to the market.
Role type
Senior Regulatory Affairs Specialist
Builds
Medical device products and therapies for patients with neurological, spinal, and pelvic health conditions
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device industry experience, Class III device (PMA) knowledge, FDA submission expertise, EU MDR compliance, ISO 14971 risk management, ISO 13485 quality standards, regulatory negotiation, license maintenance, post-market vigilance reporting, labeling review, marketing claim development
Preferred skills
Advanced degree in scientific discipline, biotechnology environment experience, engineering or cybersecurity experience
Technologies
MS Office, MS Project, Adobe Acrobat, Agile
Responsibilities
Provide expert advice on regulatory requirements, prepare and submit regulatory filings to FDA, EU MDR, and other agencies, negotiate approval with regulators, assist with license maintenance and manufacturing site registrations, collaborate with business unit RAS and international staff, resolve regulatory issues with engineering partners, support regulatory compliance activities including audits and recalls, provide feedback to product development teams, interact directly with FDA and international regulatory agencies
Seniority
Senior, hands-on IC