Manager, Regulatory Affairs and Compliance
Core
Develops, implements, and maintains a comprehensive Quality & Regulatory Affairs system for medical devices, ensuring compliance with domestic and international regulations while leading regulatory submissions and post-market surveillance.
Role type
Manager, Regulatory Affairs and Compliance
Builds
Regulatory strategies, submissions (510(k)s, Technical Files), and compliance systems for medical devices
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, FDA QSR, ISO13485, EU MDR, Health Canada, project management, MDR reporting, recall management, document control, third-party testing oversight, internal/external audit support
Preferred skills
Japanese/Australian/Brazilian regulatory knowledge, ISO 14971, IEC 60601, UL certification process, RAPS RAC, ASQ CQA
Technologies
FDA QSR, ISO13485, EU MDR, Health Canada, ISO 14971, IEC 60601
Responsibilities
Manage personnel activities and performance reviews for Regulatory Affairs and Document Control; Prepare and maintain regulatory submissions for US and International markets; Review and summarize post-market surveillance feedback; Evaluate and document reportable events and submit MDRs; Maintain device registrations, listings, and certifications; Provide technical guidance to product development teams; Oversee document control efforts and internal audit programs.
Seniority
Manager, hands-on leadership