Senior Regulatory Affairs Specialist - Medical Devices- FDA focus

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, WOM 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

As a Senior Regulatory Affairs Specialist - FDA, you will be the go-to expert for U.S. regulatory strategy and compliance. In this role, you'll lead FDA submission activities, serve as the primary liaison with regulatory authorities, and partner with cross-functional teams to ensure our products meet the highest standards of safety and effectiveness.

This role is responsible for developing and executing FDA submission plans, including 510(k) applications, and serving as the primary liaison with regulatory authorities. The specialist ensures adherence to design control and change management processes, supports audits and customer interactions, and manages safety-related complaints in collaboration with Medical Affairs.

Additionally, the position drives initiatives to maintain the Quality Management System and monitors evolving regulatory requirements to keep the organization compliant and competitive.

Primary Responsibilities

• Develop and execute regulatory strategies for FDA approval, including preparation and submission of 510(k) applications and related documentation.

• Monitor regulatory developments (FDA guidance, 21 CFR, etc.)

• Take responsibility for the compilation of other approval-relevant documents including free sales certificates, legalizations, other declarations, and certificates

• Act as the primary liaison with the FDA and other regulatory authorities; coordinate Pre-Sub meetings and monitor regulatory changes.

• Evaluate design changes for regulatory impact and ensure compliance with design control processes.

• Serve as the regulatory interface with customers, notified bodies, and external partners, support audits and inspections.

• Manage safety-related complaints and post-market surveillance activities in collaboration with Medical Affairs.

• Maintain and improve Quality Management System processes to ensure compliance with quality, safety, and environmental standards.

Required Experience, Education, Skills, Training and Competencies

• 5+ years of related experience

• Bachelor's degree

• Advanced training "Manager Regulatory Affairs for Medical Devices"

• Experience preparing and managing FDA submissions such as 510 (k) and ideally, PMA applications

Travel Requirements

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

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