Senior Regulatory Specialist (Canada)
Remote · Canada
Job Summary
Senior Regulatory Specialist position in Canada focusing on aligning regulatory strategies with commercial priorities, collaborating with RA Platform teams, managing regulatory submissions for medical devices, maintaining regulatory data in ERP/RIM systems, and supporting audits/inspections. The role emphasizes developing regulatory knowledge for responsible countries, partnering with commercial teams to align product approvals with revenue plans, and leading process improvements within Regulatory Affairs. Candidates should have a Bachelor's degree in a technical field and 8+ years of regulatory submissions experience in medical devices, with strong communication and project-management skills.
Required Qualifications
- Bachelor’s degree in a technical field (biological, physical, engineering, regulatory, legal or related)
- 8+ years of Regulatory Submissions experience in the medical device industry
- Deep knowledge of medical device regulations (Quality System Standards/Regulations/Laws, including ISO 13485, etc., Design Controls)
- Ability to identify and frame concepts with understanding of business impact
- Strong project management, communication, attention to detail, continuous improvement, analytical skills, strategic leadership, team development, results orientation
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