Senior Regulatory Affairs Associate

Clarion Medical Technologies Inc.; Cambridge; On-site; CAD 68,000 - 72,000; Full time

Benefits offered by this job

Competitive base pay

Variable compensation

Extended healthcare

Pension match

Paid vacation

Personal days

Mentorship

Education programs

Lunch & learns

Community volunteer time

Open office

Job summary

Clarion Medical Technologies is seeking a Senior Regulatory Affairs Associate to ensure global regulatory compliance, support EU MDR projects, and manage technical documentation for submissions and audits.

Based in Canada, this role reports to the Manager of Regulatory Affairs and Quality Compliance and focuses on registration, quality procedures, and post-market compliance.

Qualifications

• Bachelor's degree in science or related field.
• Bachelors required with 3–5 years regulatory experience.
• Familiarity with EU MDR 2017/745, HPB guidelines, and global compliance standards.
• Ability to interpret regulatory requirements for company compliance.
• Strong research, logic, and medical knowledge.

Responsibilities

• Provide technical support for regulatory submissions and compliance requirements.
• 2: Manage scientific, medical, clinical, and manufacturing documentation for new product registrations.
• 3: Act as a regulatory expert for government requests and product changes.
• 4: Lead EU MDR projects and align with global regulatory standards.
• 5: Develop, update, and maintain internal quality procedures and product documentation.
• 6: Prepare and maintain Technical Files and Design Dossiers for CE marking.
• 7: Support audits from FDA, Notified Bodies, and other authorities.
• 8: Conduct internal and external audits, monitor compliance trends, and manage risks.
• 9: Assist with post-market compliance, complaint handling, and technical file tracking.
• 10: Represent LUVO as a Regulatory Representative for compliance excellence.

Skills

Regulatory affairs

EU MDR familiarity

Attention to detail

Documentation management

Regulatory submissions

Education

Bachelor's degree in science or related field

Job description

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.

Estimated Compensation Range: $68,000 - $72,000 annually (base + bonus). The estimated range reflects the budgeted compensation for the position. Final offers may vary based on the factors such as skill set, experience, qualifications, performance, and other job related considerations.

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.