Principal Regulatory Affairs
Core
Develop global regulatory strategies for new product approvals and maintain existing products in the medical device industry.
Role type
Principal Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions (510(k), CE Technical Files) and product launches for global markets
Domain
Medical Devices / Regulatory Affairs
Required skills
Global regulatory strategy, FDA and notified body negotiation, 510(k) and CE Technical File authoring, risk management, design control, regulatory intelligence, audit management, process improvement
Preferred skills
None stated
Technologies
None stated
Responsibilities
Determine requirements for product submissions and regulatory filings; monitor regulatory changes and update procedures; communicate regulatory requirements to internal/external customers; review supporting evidence for compliance; lead regulatory filings and direct communication with regulators; manage product labeling and claims; define timelines for technical deliverables; oversee internal and external audits.
Seniority
Principal, strategic leadership & expert