Lead Regulatory Affairs Specialist (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, Novanta Medical develops devices and accessories so that doctors can operate with small cuts. We produce 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.

Summary

The Lead Regulatory Affairs Specialist ensures that:

medical devices and the steps involved in developing, testing, and marketing them meet all applicable regulatory requirements, and

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.

Operational responsibility is an important part of the role.

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 Design Control and Design Change processes:

Support the development and updating of the design control processes, and of the parallel applicable processes and guidelines

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, in particular Risk analysis/risk management, clinical evaluation, design validation/design verification plans and protocols, software documentation, instructions for use and product labeling

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, e.g. for clinical evaluation, biocompatibility, electrical safety, cyber security etc.

Regarding Customer Support and External Contacts:

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

Regarding Safety-related incidents:

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

General Tasks

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.

Required Experience, Education, Skills, Training and Competencies

Long-term (5-8 years) of extensive and well-founded functional professional experience

Completed studies in the natural sciences, engineering, medical or comparable field

Advanced training “Manager Regulatory Affairs for Medical Devices”

Languages: English Level CEFR C1, German Level CEFR B2

Quality-oriented, reliable, and dependable

Self-motivated

Team player

Independent and self-reliant

Excellent communication skills

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

Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.