Manager Regulatory Affairs; 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.

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia‑Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.

This position is part of Novanta’s Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, Advanced Surgery develops devices and accessories so that doctors can operate with small cuts. We produce eg Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures.

Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate.

The Manager Regulatory Affairs is responsible for regulatory submissions and approvals for initial placing and maintaining the devices on the market are timely performed. To make this happen the employee anticipates and plans appropriate tasks and coordinates relevant cross‑functional teams. Your expertise will support successful product launches and compliance throughout the product lifecycle.

• Technical and disciplinary management of the subordinate areas and employees.
• Designing, developing and optimizing the structure and processes of the subordinate areas.
• Assignment, development and scheduling of employees according to requirements and skills.
• Conducting regular employee appraisals.
• Carrying out and implementing resource and budget planning for the subordinate areas.
• With regard to occupational safety and environmental protection, the prevention of occupational accidents and environmental damage, occupational diseases and work‑related health hazards, the manager is entrusted with the responsibility for creating and maintaining facilities for his area and for issuing instructions and taking other measures to ensure, maintain and improve occupational safety and environmental protection.

• Management of or responsibility for the compilation of approval‑relevant documents including free sales certificates, legalizations, other declarations, and certificates.
• 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, assessment of compliance with the essential requirements, preparation, and release of declarations of conformity.

• Interface between the RA departments of customers, the notified body and authorities.
• Support for audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR.

• Management of safety‑related complaints in cooperation with the Medical Affairs team.

• Initiation and management of the processing of measures to maintain the QMS (e.g. process adaptation).
• Initiation of innovation process.
• Strict compliance with the…