Our client is a rapidly growing medical device company that is on an exciting path of significant adoption/expansion globally. They are looking for top talent to join their team in a newly created Regulatory Affairs Associate position. This position will mostly work remotely with a small requirement to visit the office for larger team meetings in Markham (roughly once per month).

Regulatory Affairs:

- Support worldwide registration and approval activities and assist global distributors to place medical devices developed, manufactured, and imported by the company within global markets.
- Assist in preparing timely regulatory submissions for product registration, amendments, renewals, and responses to regulatory agencies (FDA, Health Canada, European Competent Authorities via Notified Bodies, and other international regulators)
- Maintain and update technical documentation throughout the life cycle of products in compliance with new and changing regulations and standards
- Maintain regulatory records, submission files, records in registration databases, and regulatory tracking tools to ensure documentation is accurate, complete, current, and inspection-ready.
- Support the use and maintenance of regulatory electronic submission portals and enrollment systems.
- Ensure that requirements of ISO 13485, MDSAP, SOR/ 98-282, FDA QMSR (21 CFR Part 820), EU MDR 2017/745 and other applicable global regulations, are applied with an emphasis on risk management processes (as per ISO 14971)
- Obtain country-specific registration requirements from distributors and maintain the global product registration database.




- Prepare and submit annual licence renewals and maintenance activities for Health Canada and other regulatory jurisdictions as assigned.
- Manage all notarization, authentication, and legalization logistic activities for global submissions.
- Assist with regulatory change assessments for proposed product and process changes to assess regulatory impact and develop necessary vigilance reporting documents.
- Support internal, external and supplier audits (when applicable) and assist in external conformity assessments and facility audits from global regulatory agencies or other third parties
- Maintain up-to-date, working knowledge of worldwide regulatory affairs and of legislation and regulatory requirements pertinent to the products of the company
- Participate in continuous improvement initiatives through corrective & preventive actions to strengthen the reliability of products and processes
- Other duties as assigned by Management

Education:

- A post-secondary degree/diploma in Science, Engineering or in a relevant technical discipline (e.g., biology, chemistry)
- Regulatory Affairs & Quality Assurance certification is highly desirable and Auditor certifications are an asset

Experience:

- Minimum 1 to 3 years’ experience in regulatory affairs for medical devices. Experience supporting regulatory submissions for medical devices in Canada, the United States, and/or Europe is preferred




- Knowledge of standards for Quality Management System requirements, including ISO 13485, FDA QMSR, MDSAP with an understanding of the relationships between applicable requirements and associated quality system processes
- Knowledge of medical device regulations in Canada, US and Europe, working knowledge of Technical Documentation and GSPR requirements under EU MDR 2017/745 is desired
- Experience communicating with global distributors and regulatory authorities is an asset
- Familiarity with regulatory change assessments and guidance documents used to determine regulatory reporting requirements
- Familiarity with risk management and change management processes using standards such as ISO 14971, IEC 60601-1, IEC 60601-1-2, and IEC 62366-1 etc.
- Proficiency in using general office productivity software (Microsoft Office, Microsoft Excel etc.) for communication and documentation purposes

Skills:

- Detail-oriented, independent, and an aptitude for interpretation and application of medical device regulations and guidances to regulatory submissions and responses
- Robust technical writing, proofreading, and document review skills.
- Ability to organize and prioritize multiple regulatory projects simultaneously.
- Able to work effectively and independently at the office and remotely
- Must be willing to learn and be a team player
- Sense of urgency, self-motivated, flexible
- Excellent English communication skills, both oral and written
- Excellent interpersonal communication skills and judgment
- Ability to lift up to 25 lbs/10 kg

Pay: $75,000.00-$85,000.00 per year

Benefits:

- Dental care
- Extended health care
- Paid time off

Work Location: Remote

📌 Regulatory Affairs Associate - Medical Devices (Canada)
🏢 CMC Recruitment Solutions
📍 Canada