Manager Regulatory Affairs
Core
Lead the Regulatory Affairs team to develop strategies for domestic and international approvals of medical devices.
Role type
Manager, Regulatory Affairs
Builds
Regulatory strategies and compliance frameworks for medical device product divisions
Domain
Medical Devices / Healthcare Regulatory
Deliverable
client delivery
Required skills
Medical device regulations (pre/post-market), regulatory filing management, team leadership, project management, policy development, stakeholder communication
Preferred skills
RAC Certification, SAP experience, 510(k) and CE technical file writing, environmental safety regulations (EPA, Prop 65, FIFRA, OSHA, CPSC, DOT, VAWD)
Technologies
SAP
Responsibilities
Guide regulatory decision-making, complete and maintain regulatory filings, communicate regulatory requirements to internal/external customers, monitor regulatory environment changes, manage staff including hiring and performance reviews
Seniority
Manager, people management