Job Description
ClinChoice is seeking a Regulatory Affairs Specialist Consultant for a 12‑month contract (renewable) in Canada. The role provides the opportunity to work directly for a sponsor while benefiting from a global CRO environment.
Role
Employment Type: Contract
Location: Hybrid – Canada (2–3 days per week)
Responsibilities
- Prepare, review, and support medical device registration submissions and post‑market regulatory activities.
- Document review of product changes and the management of any required submissions.
- Prepare and/or review letters of authorisation, cover letters for registration certificates, declarations, power of attorney, etc., to ensure accuracy, appropriateness and consistency of documents intended for regulatory submissions.
- Extract available documents from the document management databases and operational systems to assist in the preparation of dossiers.
- Ensure compliance with curr...