Job Brief:
We are seeking a Regulatory Affairs Officer to support our compliance, product registration, and regulatory submission activities across the Canadian market. This role ensures that our products, processes, and documentation meet all applicable federal and provincial regulatory requirements, including Health Canada guidelines and industry‑specific standards.

Responsibilities:

• Prepare, review, and submit regulatory filings to Health Canada and other relevant authorities.

• Maintain up‑to‑date knowledge of regulatory requirements, guidance documents, and policy changes affecting our products.

• Coordinate product registrations, licensing, renewals, and amendments.

• Develop and maintain regulatory documentation, technical files, and compliance records.

• Support internal teams (Quality, R&D, Operations, Marketing) with regulatory interpretation and compliance guidance.

• Participate in audits and inspections, ensuring timely responses and corrective actions.

• Monitor post‑market compliance, including incident reporting and product changes.

• Liaise with external partners, consultants, and regulatory agencies as needed.

Skills Required:

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field.

• 2–5 years of experience in regulatory affairs, preferably within Canada.

• Strong understanding of Health Canada regulations, including the Food and Drugs Act, Medical Devices Regulations, or other sector‑specific frameworks.

• Excellent attention to detail and strong technical writing skills.

• Ability to manage multiple projects and deadlines in a fast‑paced environment.

• Experience with quality systems (e.g., ISO 13485, GMP) is an asset.