Regulatory Affairs Specialist
Cook Group
contract
Posted on:
Location Type: Office
Location: Stouffville • 🇨🇦 Canada
Visit company websiteJob Level
JuniorMid-Level
About the role
- Support departmental activities by ensuring all products have appropriate Health Canada license and approval for sale.
- Assist with Special Access Program interactions.
- Monitor new and existing part numbers to ensure that all products sold are licensed.
- Ensure completion and submission of license amendments as required and determine applicable fees.
- Assist with annual renewal process.
- Prepare mandatory reports for ROEB.
- Monitor Health Canada website for policy changes.
- Ensure submissions comply with administrative policies.
- Gather information from manufacturers and evaluate suitability for application.
- Assist with product recalls
- Communicate with Regulatory, Quality and associate personnel at other Cook Group companies.
- Maintain Quality Systems Documentation.
- Coordinate internal audit process.
Requirements
- Legally entitled to work in Canada
- 2 years experience working with federal regulations respecting medical devices and quality systems.
- Additional experience or specialized training in healthcare would be an asset
- Appropriate clinical post-secondary education in a subject relating to nursing or medical/life sciences.
- Must be confident, energetic positive, self-starter and results-driven.
- Ability to form trusting and professional relationships throughout the organization and with Health Canada officials.
- Highly effective communicator.
- Able to travel outside of Canada
Benefits
- Cook is committed to providing accommodations for people with disabilities.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Health Canada licensingregulatory compliancequality systemslicense amendmentsmandatory reportingproduct recallsaudit coordinationfederal regulationsmedical device regulationsclinical education
Soft skills
communicationrelationship buildingself-starterresults-drivenconfidenceenergypositivitytrust formationprofessionalismteam collaboration