Regulatory Affairs Specialist Consultant

Clin Choice 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.

Employment Type:

Contract

Location:

Hybrid – Canada (2–3 days per week)

• 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 current good documentation practices (cGDP) including proof‑reading, formatting, indexing and record‑keeping.
• Assist team members in answering inquiries and providing required documents and information using various search tools and systems.
• Maintain tracking tools to ensure up‑to‑date information and traceability of all regulatory data/documentation.
• File and retrieve documents as directed per company policies and procedures.
• Communicate effectively with internal and external teams and/or clients regarding the status of deliverables to ensure timely and satisfactory completion.
• Provide support to internal and external teams to address technical inquiries and provide requested information.
• Participate in group meetings and provide tactical approaches to addressing issues of basic complexity.
• Support implementation activities related to labeling, change control, and SOPs.
• Collaborate with cross‑functional teams to collect required documents.
• Other duties as assigned.

• Minimum of three years of experience in regulatory affairs preparing and reviewing technical documentation and submissions under Health Canada medical device regulations.
• Basic knowledge of EU MDD/MDR and ISO
  13485 or equivalent education is preferred.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Strong understanding of current Good Documentation Practices in a regulatory environment.
• Strong organisational skills, attention to detail, good planning and communication skills.
• Self‑starter capable of working in a team environment on diverse projects where minimal supervision is required.
• Excellent written and verbal communication skills.
• Detail‑oriented with strong critical‑thinking and analytical skills, keen on producing results.

Clin Choice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier‑free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling +1 (647) 724‑5709 x 301.

We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA"), personal information is collected under the authority of the Act and will only be used for candidate selection.