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 & Tools
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