Regulatory Affairs Officer â Ontario, Canada

Mississauga - Canada

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

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 industryâspecific standards.

Responsibilities:

Prepare review and submit regulatory filings to Health Canada and other relevant authorities.
Maintain upâtoâdate 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 postâmarket compliance including incident reporting and product changes.
Liaise with external partners consultants and regulatory agencies as needed.

Skills Required:

Bachelors degree in Life Sciences Pharmacy Engineering or a related field.
25 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 sectorâspecific frameworks.
Excellent attention to detail and strong technical writing skills.
Ability to manage multiple projects and deadlines in a fastâpaced environment.
Experience with quality systems (e.g. ISO 13485 GMP) is an asset.

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 inc...