Senior Regulatory Affairs Associate

Cambridge, ON
On-site
Posted Oct 3, 2026
1 position

Opens an external site

Employment type: Full-time
Experience level: Mid-level · 2+ years
Minimum education: Bachelor’s degree
Posting language: English
Working hours: 38 hours per week

Job summary

The Senior Regulatory Affairs Associate will manage global regulatory compliance, including EU MDR projects and technical documentation for submissions. They will also support audits, maintain quality procedures, and act as a regulatory resource for product changes and government requests.

Job details

Clarion Medical Technologies, a part of Richards Group, 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 Manager 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. This position is for an open vacancy. 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.

What you’ll do

Requirements

Candidates must hold a bachelor's degree in science or a related field and possess 3–5 years of regulatory affairs experience. Strong knowledge of EU MDR 2017/745, HPB guidelines, and global compliance standards is required.