Lead Regulatory Affairs Specialist Medical Devices (m/f/d)

Build a career powered by innovations that matter! At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.

Requirements

• Management of or responsibility for the compilation of approval-relevant documents
• Management of or responsibility for compiling documents for documentation evaluations by notified bodies and competent authorities worldwide
• Management of or responsibility for the control/acceptance of technical documentation as part of the conformity assessment procedure
• Support the development and updating of the design control processes
• Subject-specific involvement in the implementation of the risk management process, clinical evaluation, and usability file
• Control and sole responsibility for reviewing/releasing approval-relevant documents as part of the design control process
• Management of/ responsible for the regulatory evaluation of change orders and checking for approval relevance
• Management of/ responsible for processing RA-related general inquiries
• Subject Mater Expert for the interpretation of standard requirements
• Interface between the RA departments of customers, the notified body and authorities
• Support of audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR
• Processing of safety-related complaints in cooperation with the Medical Affairs team
• Initiating and monitoring processing of measures to maintain the QMS (e.g. process adaptation)
• Strict compliance with the quality, occupational safety and environmental regulations.
• Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist.