Senior Regulatory Affairs Specialist – Medical Devices

A leader in the musculoskeletal industry, Zimmer Biomet develops the world’s best treatment and surgical solutions, enabling thousands of people around the world to regain mobility and active living.

From pain-free walking to mountain climbing, our client offers a complete range of orthopaedic prostheses.

Renowned for offering a highly stimulating work environment and highly competitive benefits and advantages, Zimmer Biomet is looking for a dynamic individual, stimulated by collaboration within a multidisciplinary team, to fill the position:

Senior Regulatory Affairs Specialist – Medical Devices

Location: Montreal, Qc

Responsabilities :

As a member of the Regulatory Affairs team, you take part in the regulatory submission process (Canada, United States and Europe). You bring your expertise in international medical product registration dossiers and assist the product development teams to provide regulatory expertise.

More specifically, you will :

• Prepare and submit regulatory submissions to Canadian, American and European authorities (Health Canada, FDA, etc.) for the marketing of medical devices.
• Collect the information necessary to prepare regulatory submissions from the various teams.
• Support foreign regulatory agencies and international distributors in their requests.à
• Participate in the implementation of regulatory strategies for all stages of product development and modification.
• Evaluate proposed product changes and determine their impact on the regulatory status of medical devices.
• Review promotional and advertising materials and product labelling to ensure compliance with Canadian, U.S. and European regulations.
• Apply FDA regulations to business practices and advise design and development teams.

Essential Skills and Experience :

• Bachelor’s degree in Engineering or Science with over 5 years of experience with regulatory submission processes (Canada, US and Europe).
• 2 years in the field of medical devices, preferably in orthopaedics;
• Ability to readjust your priorities and demonstrate versatility and flexibility;
• Bilingual, you have excellent oral and written communication skills in English.

If you recognize yourself in this position, don’t miss this opportunity and communicate with Sabri Ben Abdallah, Business Partner -Talents 514.287.0770 / sbenabdallah@leducrh.ca

This selection mandate is managed by the consulting firm LEDUC RH. Please send your application to the following address: cv@leducrh.ca