Senior Regulatory Affairs Associate

Clarion Medical Technologies Inc.; Ontario; On-site; CAD 60,000 - 100,000; Full time

Job summary

An established industry player in medical technology is seeking a Senior Regulatory Affairs Associate to ensure global compliance and support EU MDR projects. This role offers a dynamic environment where you can leverage your expertise in regulatory compliance and quality assurance. You'll manage technical documentation, lead projects, and conduct audits, contributing significantly to the company's mission of empowering healthcare providers. With a generous compensation package, fantastic benefits, and a commitment to professional development, this is an exciting opportunity to shape the future of medical technology in Canada.

Benefits

Generous compensation package

Extended healthcare benefits

Personal spending account

Pension plan with employer match

Paid vacation time

Work/life balance

Mentorship and professional development

Paid education and training programs

Collaborative office environment

Qualifications

• 3-5 years of experience in Regulatory Affairs.
• Strong research and attention to detail.

Responsibilities

• Manage regulatory submissions and compliance requirements.
• Lead EU MDR projects and ensure global alignment.
• Conduct internal and external audits.

Skills

Regulatory Compliance

Quality Assurance

Technical Documentation

Attention to Detail

Research Skills

Education

Bachelor’s degree in Science

Job description

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 Senior Regulatory Affairs Associate will play a vital role in ensuring global regulatory compliance, supporting EU MDR projects, and handling technical documentation for submissions and audits. This role is ideal for an experienced professional with a strong background in regulatory compliance, quality assurance, and new product registration.

The successful applicant will:

• Provide technical support for regulatory submissions and compliance requirements.
• Manage scientific, medical, clinical, and manufacturing documentation for new product registrations.
• Act as a resource on regulatory matters, including government requests and product changes.
• Lead EU MDR projects and ensure alignment with global regulatory standards.
• Develop, update, and maintain internal quality procedures and product documentation.
• Prepare and maintain Technical Files and Design Dossiers for CE Marking.
• Support audits from FDA, Notified Bodies, Competent Authorities, and other regulatory agencies.
• Conduct internal and external audits, monitor compliance trends, and manage risks.
• Assist with post-market compliance, complaint handling, and technical file tracking.
• Represent LUVO as a Regulatory Representative, ensuring industry-leading compliance.

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

• Bachelor’s degree in science or a related field.
• 3–5 years of experience in a Regulatory Affairs role.
• Strong research, logic, attention to detail, computer expertise, and medical knowledge.
• Familiarity with EU MDR 2017/745, HPB guidelines, and global compliance standards.
• Ability to interpret and apply regulatory requirements to ensure company-wide compliance.

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.