Regulatory Affairs Officer – Ontario, Canada

Recooty; Mississauga; Presencial; CAD 70.000 - 110.000; Jornada completa

Descripción de la vacante

Recooty is seeking a Regulatory Affairs Officer to support compliance, product registration, and regulatory submissions across the Canadian market. This role ensures our products and documentation meet Health Canada guidelines and province-specific requirements.

The ideal candidate will manage filing workflows, maintain up-to-date regulatory knowledge, and collaborate with Quality, R&D, and Operations to sustain post-market compliance and successful registrations.

Formación

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
• 2–5 years of regulatory affairs experience, preferably in Canada.
• Strong understanding of Health Canada regulations (e.g., Food and Drugs Act, Medical Devices Regulations).
• 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 (ISO 13485, GMP) is an asset.

Responsabilidades

• Prepare, review, and submit regulatory filings to Health Canada and other authorities.
• Maintain up-to-date knowledge of regulatory requirements 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 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.

Conocimientos

Regulatory filings

Project management

Technical writing

Attention to detail

Health Canada regulations

Educación

Bachelor's degree in Life Sciences

Bachelor's degree in Pharmacy

Descripción del empleo

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.