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-at-pi-cardia)
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, labeling reviews, audit support
Preferred skills
Class III/implantable device experience, international market knowledge (Canada, UK, Australia, Japan), RAC certification
Technologies
FDA, EU MDR, ISO 13485, ISO 14971
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; Participate in audits and inspections; Maintain regulatory records and ensure timely renewals.
Seniority
Mid-Senior, hands-on IC