Lead Regulatory Affairs Specialist (m/f/d)

Join Novanta's Advanced Surgery business unit and work on developing devices and accessories for minimally invasive medicine. As a Lead Regulatory Affairs Specialist, you will ensure that medical devices meet regulatory requirements and coordinate cross-functional teams.

Requirements

• Management of approval-relevant documents
• Compiling documents for documentation evaluations
• Control and acceptance of technical documentation
• Supporting design control processes
• Subject-specific involvement in risk management and clinical evaluation
• Management of regulatory evaluation of change orders
• Subject matter expert for standard requirements
• Interface between RA departments and external contacts
• Processing of safety-related complaints
• Monitoring processing of measures to maintain QMS

Benefits

• Opportunity to work on innovative projects
• Collaborative team environment
• Professional development opportunities
• Competitive salary and benefits package
• Employee relocation (sponsored by company)