Quality and Regulatory Manager
Smarter Alloys
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Canada
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About the role
- Own and maintain the ISO 13485 Quality Management System, ensuring ongoing compliance and effectiveness.
- Lead internal and external audits, including ISO audits, customer audits, and regulatory inspections.
- Support regulatory activities for medical device products, including FDA establishment registration and listing.
- Guide regulatory requirements for new product development from concept through commercialization.
- Maintain and improve quality documentation, including SOPs, work instructions, risk management files, and technical documentation.
- Oversee corrective and preventive actions (CAPA), nonconformance management, and continuous improvement initiatives.
- Support supplier qualification, monitoring, and quality agreements as required.
- Collaborate cross-functionally with engineering, production, procurement, and business development teams.
- Train and support internal teams on quality system requirements and regulatory expectations.
- Serve as the primary point of contact for quality and regulatory matters internally and externally.
Requirements
- Bachelor’s degree in Engineering, Science, or a related technical discipline
- 4+ years of experience in quality and regulatory roles within the medical device industry
- Strong working knowledge of ISO 13485 and FDA Quality System Regulation
- Demonstrated experience leading audits and managing regulatory inspections
- Proven ability to manage and improve a QMS in a hands-on environment
- Strong documentation, organizational, and communication skills
- Ability to work independently and exercise sound judgment in a regulated setting.
Benefits
- Competitive compensation package
- Full benefits
- Paid vacation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ISO 13485FDA Quality System RegulationQuality Management System (QMS)Corrective and Preventive Actions (CAPA)Risk managementTechnical documentationSOPsWork instructionsAuditingRegulatory inspections
Soft skills
Organizational skillsCommunication skillsJudgmentCollaborationTrainingLeadershipIndependenceProblem-solvingAttention to detailContinuous improvement