Regulatory Affairs Specialist
Core
Drive global regulatory strategies and ensure compliance for cardiovascular medical devices throughout the product lifecycle. (via careerplan.io/jobs/A5-00B-2A-C63-regulatory-affairs-specialist)
Role type
Regulatory Affairs Specialist
Builds
Regulatory submissions, registrations, and technical dossiers for medical devices
Domain
Medical Devices / Cardiovascular
Required skills
FDA regulations, EU MDR, ISO 13485, ISO 14971, ECO management, regulatory submissions, risk management, audit support, Class III/implantable device experience
Preferred skills
International market experience (Canada, UK, Australia, Japan), RAC certification
Technologies
None stated
Responsibilities
Prepare and maintain regulatory submissions for FDA and EU MDR markets; manage Engineering Change Orders (ECOs) from a regulatory perspective; compile and update technical documentation and regulatory dossiers; monitor changes in regulatory requirements; collaborate with R&D, QA, Clinical, Manufacturing, and Marketing teams; support audits, inspections, and quality management system activities; maintain regulatory records and ensure timely renewals.
Seniority
Mid-Senior, hands-on IC