Manager Regulatory Affairs (m/f/d)

Novanta Inc.; Berlin; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Novanta Inc. is seeking an experienced Manager Regulatory Affairs to lead regulatory submissions and lifecycle compliance for medical devices. You will coordinate cross‑functional teams to ensure timely product registrations, approvals, and ongoing conformity across global markets.

The role requires deep regulatory expertise, a background in natural sciences or engineering, and strong leadership skills to drive quality and safety throughout the product lifecycle. Travel up to 10% may be required.

Qualifikationen

• Long-term (8–12 years) of extensive and well‑founded professional experience.
• Experience as manager preferred.
• Completed studies in the natural sciences, engineering, medical or comparable field.
• Extensive expertise in regulatory affairs with a medical device focus.
• Advanced training in Manager Regulatory Affairs for Medical Devices.

Aufgaben

• Compile approval-relevant documents including free sales certificates and declarations.
• Prepare documentation for evaluations by notified bodies and authorities worldwide.
• Control/acceptance of technical documentation for conformity assessment.
• Interface between regulatory affairs, customers, notified bodies and authorities.
• Manage safety-related complaints in cooperation with Medical Affairs.
• Maintain and improve the QMS and related processes.

Kenntnisse

Regulatory affairs

People management

Cross-functional leadership

QMS

Ausbildung

B.Sc. in natural sciences/engineering/medical

Jobbeschreibung

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.

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‑found 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*.

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)

Novanta is proud to be an equal employment opportunity and affirmative action workplace. We consider all qualified applicants 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. Please call [phone] if you need a disability accommodation for any part of the employment process.

Solving complex challenges, delivering innovations that matter! Novanta is a leading global supplier of core technology solutions that give medical, life science, and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary expertise and competencies in precision medicine, precision manufacturing, robotics and automation, and advanced surgery with a proven ability to solve complex technical challenges. This enables Novanta to engineer proprietary technology solutions that deliver extreme precision and performance, tailored to our customers' demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation, the Novanta Growth System, and our customers’ success.

Novanta’s common shares are quoted on Nasdaq under the ticker symbol "NOVT".