Manager Regulatory Affairs (m/f/d)

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Business Unit Overview

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.

Position Details

Summary

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.

Management Responsibilities:

• 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.

Primary Responsibilities

Regarding Regulatory approval of medical devices:

• 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

Regarding Customer Support and External Contacts:

• 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

Regarding Safety-related incidents:

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

General Tasks

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

Required Experience, Education, Skills, Training and Competencies

• Long-term (8-12 years) of extensive and well-founded functional professional experience
• Experience as manager preferred
• Knowledge, creativity, ability and willingness to take responsibility to put multiple and sometimes contradictory inputs into context
• Completed studies in the natural sciences, engineering, medical or comparable field
• Possess extensive expertise in regulatory affairs, with a specialized background in the medical device industry
• Advanced training “Manager Regulatory Affairs for Medical Devices”
• Languages: English Level CEFR C1*, German Level CEFR B2*
• Independent, Quality-oriented, reliable, and dependable
• Self-motivated
• Team player
• Be able to effectively communicate with internal stakeholders, regulatory agencies, and external partners
• Well-structured and systematic way of working
   

Travel Requirements 

• Willingness to travel to different NOVT locations and business partners - Up to 10% traveling time
   

Physical Requirements

• None

(*) Common European Framework of Reference for Languages (CEFR)

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