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About the Role
The Manager Regulatory Affairs is responsible for timely regulatory submissions and approvals for placing and maintaining devices on the market. This role supports successful product launches and compliance throughout the product lifecycle by planning tasks and coordinating cross-functional teams.
Responsibilities
- Provide technical and disciplinary management of subordinate areas and employees.
- Design, develop, and optimize the structure and processes of subordinate areas.
- Assign, develop, and schedule employees according to requirements and skills.
- Conduct regular employee appraisals.
- Carry out and implement resource and budget planning for subordinate areas.
- Ensure and maintain occupational safety and environmental protection within the area of responsibility.
- Manage or be responsible for the compilation of approval-relevant documents, including free sales certificates, legalizations, other declarations, and certificates.
- Manage or be responsible for compiling documents for documentation evaluations by notified bodies and competent authorities worldwide.
- Manage or be responsible for the control/acceptance of technical documentation as part of the conformity assessment procedure, assess compliance with essential requirements, and prepare/release declarations of conformity.
- Act as the interface between RA departments of customers, the notified body, and authorities.
- Support audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR.
- Manage safety-related complaints in cooperation with the Medical Affairs team.
- Initiate and manage the processing of measures to maintain the QMS (e.g., process adaptation).
- Initiate the innovation process.
- Ensure strict compliance with quality, occupational safety, and environmental regulations.
- Implement instructions from the quality/environmental management representative and the occupational safety specialist.
Requirements
- Long-term (8-12 years) of extensive and well-founded functional professional experience.
- Experience as a manager is preferred.
- Possess knowledge, creativity, ability, and willingness to take responsibility to put multiple and sometimes contradictory inputs into context.
- Possess extensive expertise in regulatory affairs, with a specialized background in the medical device industry.
- Willingness to travel to different NOVT locations and business partners - Up to 10% traveling time.
Skills
- English Level CEFR C1
- German Level CEFR B2
- Independent
- Quality-oriented
- Reliable
- Dependable
- Self-motivated
- Team player
- Effective communication with internal stakeholders, regulatory agencies, and external partners
- Well-structured and systematic way of working
Location
- The Americas
- Europe
- Asia-Pacific
Work Type
- Full-time
Experience Level
- 8-12 years of functional professional experience
- Manager experience preferred
Education Level
- Completed studies in the natural sciences, engineering, medical or comparable field
- Advanced training “Manager Regulatory Affairs for Medical Devices”
About the Company
- Novanta's innovations power technology products transforming healthcare and advanced manufacturing.
- The company creates engineered components and sub-systems for global customers, delivering extreme precision and performance for mission-critical applications.
- Novanta operates as one global team with over 26 offices in The Americas, Europe, and Asia-Pacific.
- The company fosters a culture that embraces teamwork, collaboration, and empowerment.
- The Advanced Surgery business unit specializes in Minimally Invasive Medicine, developing devices and accessories such as cameras, insufflators, medical pumps, and tubing to aid doctors in performing surgeries with small incisions.
Equal Opportunity
- Novanta is an equal employment opportunity and affirmative action workplace.
- All qualified applicants are considered without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.
- Disability accommodation is available upon request at +1 781-266-5700.