Associate Regulatory Affairs Specialist

Cameleon RH•Pointe-Claire, QC

9d•Hybrid

About The Position

This is a hybrid position located in Pointe-Claire, offering an excellent balance between remote work and in-person collaboration. The role is permanent and full-time. By joining Medicom, you'll become part of a passionate Regulatory Affairs and Quality team recognized for its expertise and collaborative approach. You'll contribute to the development and ongoing compliance of medical devices distributed across North America and international markets, while expanding your knowledge alongside experienced professionals. Reporting to the Regulatory Affairs Manager, you will actively participate in a variety of regulatory projects that support the company's continued growth.

Requirements

Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.
One to three years of experience in Regulatory Affairs within the medical device industry or another highly regulated environment.
Experience with regulatory documentation, product registrations, regulatory submissions, or post-market activities.
Good understanding of regulatory requirements such as FDA QSR/QMSR, ISO 13485, Health Canada regulations, EU MDR, or other applicable regulatory frameworks.
Strong organizational skills and exceptional attention to detail.
Ability to manage multiple projects simultaneously while meeting deadlines.
Team-oriented mindset, ability to work independently, and excellent communication skills.

Nice To Haves

Additional training or certification in Regulatory Affairs is considered an asset.
Availability for occasional travel (less than 5% of the time).

Responsibilities

Participate in regulatory activities related to products marketed throughout North America.
Support new product development projects by assisting with the preparation and maintenance of regulatory documentation.
Contribute to product and establishment registrations, as well as license renewals.
Review and maintain product labeling to ensure regulatory compliance.
Participate in post-market surveillance activities, including regulatory assessments, vigilance documentation, and product recall support.
Respond to regulatory inquiries from commercial teams, customers, and international partners.
Assist in preparing documentation required for regulatory audits and inspections.
Contribute to the continuous improvement of regulatory processes.
Ensure compliance with applicable regulatory requirements, including FDA regulations, Health Canada requirements, ISO 13485, the European MDR, and other relevant standards.
Help maintain the quality of technical documentation and regulatory files throughout the product lifecycle.