Regulatory Affairs Associate

1 month ago

Cambridge, Canada Clarion Medical Technologies Inc. Full time

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
  • Paid vacation time and personal days
  • Monday-Friday day shift operations with work/life balance at the forefront
  • 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 Senior Director of Regulatory Affairs and Quality Compliance, the Regulatory Affairs Associate will be responsible for ensuring all regulatory submissions, documentation, and compliance activities are executed with precision. You will play a vital role in supporting key quality system projects, managing product documentation, and ensuring post-market compliance for our medical devices. This position is ideal for someone with a strong background in regulatory affairs and quality compliance, with a keen eye for detail and a passion for maintaining high standards.

This is a temporary full-time, 20-month maternity leave, contract with potential for extension.

The successful applicant will:

  • Prepare and register regulatory submissions for new product registrations, ensuring compliance with Health Products and Food Branch (HPB) guidelines and other regulatory requirements.
  • Manage scientific, medical, clinical, and manufacturing documentation related to product registration and quality compliance.
  • Facilitate eQMS (electronic Quality Management System) records for product changes, government requests, and affiliate interactions.
  • Lead key quality system projects, including complaint handling, traceability, technical file/batch work processing, and receiving inspections.
  • Ensure suppliers provide documentation and responses within specified limits, adhering to regulatory and quality standards.
  • Investigate and analyze regulatory and quality issues, providing technical support and resolutions.
  • Maintain document control, including specifications and quality databases, ensuring all documents meet regulatory requirements.
  • Monitor and analyze process and quality data to identify trends, assess risks, and ensure compliance with quality programs.
  • Collect, process, and analyze data related to complaint handling, adverse events, and mandatory reporting.
  • Ensure continual improvement and effectiveness of corporate quality systems (ISO, MDSAP, MDD/MDR, GMP) and maintain compliance with annual audits and regulatory requirements.
  • Support post-market compliance for obtained medical device licenses and assist in new product approvals (Canada, FDA, EU).
  • Help maintain the effectiveness of the eQMS platform.

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

  • Bachelor's degree (BA) in Life Sciences, Medical Technology, Regulatory Affairs, or a related field.
  • Minimum of 3 years of experience in a regulatory affairs or quality compliance role, preferably within the medical device or pharmaceutical industry.
  • Strong analytical skills and attention to detail.
  • Expertise in regulatory and quality management software and systems.
  • In-depth knowledge of medical device regulations, including ISO, MDSAP, MDD/MDR, GMP.
  • Excellent research, problem-solving, and communication skills.
  • Ability to collaborate with cross-functional teams and external stakeholders to achieve regulatory and quality goals.

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.

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