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Regulatory Affairs and Quality Compliance Manager

Hybrid
Cambridge, ON
Senior Level
full_time

Top Benefits

Competitive salary with variable compensation
Extended healthcare benefits for employee and family
Personal spending account for health and wellness

About the role

Clarion Medical Technologies, a Richards Packaging company, specializes in surgical, vision and aesthetic healthcare medical devices. Some of these products include laser technologies, diagnostic tools for early disease detection and advanced imaging systems. At Clarion, we are dedicated to empowering healthcare providers with the tools and expertise to deliver outstanding patient outcomes, while shaping the future of medical technology and aesthetics in Canada.

Why join Clarion:

  • Generous compensation package including a competitive base salary and variable compensation
  • Fantastic extended healthcare benefits for you and your family
  • Extended personal spending account to be used on health and wellness such as gym memberships
  • Pension plan with employer match contributions
  • Paid vacation time and personal days
  • Monday-Friday day shift operations with work/life balance at the forefront
  • Mentorship, professional development, and commitment to career planning
  • Paid education and training programs
  • Lunch & learns, volunteer time and a focus on supporting our community
  • Collaborative, open concept office
  • And so much more!

About the Role:

Reporting to the VP of Regulatory Affairs and Quality Compliance, the Regulatory Affairs and Quality Compliance Manager will be responsible for leading quality and compliance initiatives across product development, manufacturing, and commercialization. This role ensures adherence to industry and government standards, while driving continuous improvement in our Quality Management System (QMS). You will collaborate with cross-functional teams, oversee regulatory submissions, and represent LUVO in Canadian and global markets.

The successful applicant will:

  • Support the VP, Regulatory Affairs with submissions and manage documentation for product registration in compliance with HPB/MDEL guidelines.
  • Oversee Quality Management System (QMS) activities, audits, complaint handling, and GMP compliance including batch review and release.
  • Act as a regulatory resource for product changes, government requests, and affiliate communications, representing LUVO in Canadian and global markets.
  • Lead studies and implement best practices to improve product, process, and material quality while monitoring data trends and risks.
  • Ensure supplier documentation meets specifications and provide technical support to resolve quality issues.
  • Maintain document control, quality databases, and prepare reports aligned with quality programs and policies.
  • Collaborate with RA/QC team members on labeling, submissions, complaint handling, and continuous improvement initiatives.

We are seeking a candidate with the following experience and attributes:

  • Bachelor’s degree in science (or related field).
  • 3–5 years of experience in a regulatory role.
  • Strong research and analytical skills.
  • Detail-oriented with logical problem-solving ability.
  • Advanced computer proficiency.
  • Solid medical and regulatory knowledge.

Clarion Medial Technologies is an equal-opportunity employer and is committed to creating an inclusive employee experience for all. We firmly believe that our work is at its best when everyone feels free to be their most authentic self. If you require accommodation, please let us know how we can further support you during the recruitment process.

About Clarion Medical Technologies

Medical Equipment Manufacturing
51-200

Clarion Medical Technologies is one of Canada’s largest specialty medical technology providers. Offering innovative solutions since 1989 for Ophthalmology, Optometry, Respirology, Urology, Gynecology, ENT and Aesthetic applications, Clarion embraces technology to deliver best-in-class products that help improve the delivery of healthcare in Canada. Our product portfolio includes high performance technologies for vision enhancement and vision protection such as intra-ocular lenses, high-definition OCT diagnostic equipment as well as laser therapies for applications ranging from glaucoma and Age-Related Macular Degeneration to treatment of BPH, stones and tumours. With more than 7,000 systems installed in Canada and representing over 40 technologies, our experience means you can trust Clarion to deliver innovative solutions that improve healthcare.