Regulatory Affairs Associate

1 week 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.

  • Regulatory Affairs Associate

    1 week 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...

  • CMC Regulatory Affairs Lead

    1 week ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    Job Title:CMC Regulatory Affairs LeadJob Summary:We are seeking a highly skilled CMC Regulatory Affairs Lead to efficiently manage and deliver Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for Products across EU and ROW. The successful candidate will be responsible for building and maintaining a strong collaborative partnership with...

  • CMC Director for Regulatory Affairs

    3 weeks ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    CMC Director for Regulatory AffairsWe are seeking a highly skilled CMC Director to lead our Regulatory Affairs Chemistry Manufacturing Control (RA CMC) efforts for products across EU and ROW. The ideal candidate will have a strong background in pharmaceutical regulatory affairs and experience in managing teams to deliver high-quality CMC outcomes.The CMC...

  • CMC Regulatory Affairs Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    CMC Regulatory Affairs DirectorMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across EU...

  • CMC Regulatory Affairs Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    CMC Regulatory Affairs DirectorMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across EU...

  • CMC Regulatory Affairs Director

    1 month ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    CMC Regulatory Affairs DirectorMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across EU and...

  • CMC Regulatory Affairs Director

    1 month ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    CMC Regulatory Affairs DirectorMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across EU and...

  • CMC Regulatory Affairs Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    Job SummaryMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to lead our Regulatory Affairs Chemistry Manufacturing Control (RA CMC) efforts for our marketed products across the EU and ROW. As a key member of our team, you will be responsible for developing and implementing RA CMC strategies, managing vendor relationships,...

  • CMC Regulatory Affairs Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    Job SummaryMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to lead our Regulatory Affairs Chemistry Manufacturing Control (RA CMC) efforts for our marketed products across the EU and ROW. As a key member of our team, you will be responsible for developing and implementing RA CMC strategies, managing vendor relationships,...

  • CMC Regulatory Affairs Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    CMC Regulatory Affairs DirectorMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across EU...

  • CMC Regulatory Affairs Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    CMC Regulatory Affairs DirectorMundipharma International is seeking a highly skilled CMC Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the efficient management and delivery of Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across EU...

  • Regulatory Affairs Manager

    4 days ago

    Cambridge, Ontario, Canada The MEARIE Group Full time

    About the RoleThe Manager Regulatory Affairs & Revenue Assurance at The MEARIE Group will lead a team of regulatory analysts and oversee the preparation and management of regulatory filings and proceedings. This senior role will actively participate in the development and implementation of the Company's regulatory strategy and ensure compliance with...

  • Director, Regulatory Affairs

    5 months ago

    Cambridge, Canada The MEARIE Group Full time

    **Director, Regulatory Affairs & Revenue Assurance** GrandBridge Energy Inc. is guided by a vision to be a leader in energy transformation and driven by a mission to bridge communities to the energy future. GrandBridge Energy delivers safe and reliable electricity to 113,000 customers in the City of Brantford, the City of Cambridge, the Township of North...

  • Manager Regulatory Affairs

    6 days ago

    Cambridge, Canada The MEARIE Group Full time

    **Manager Regulatory Affairs & Revenue Assurance** **Who We Are**: GrandBridge Energy Inc. (GBE) is guided by a vision to be a leader in energy transformation and driven by a mission to bridge communities to the energy future. We are proud to provide safe, reliable electricity to over 113,000 customers across the City of Brantford, the City of Cambridge,...

  • CMC Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    About the Role:Mundipharma International is seeking a highly skilled CMC Director to lead our Regulatory Affairs team in delivering high-quality products to the market. As a key member of our team, you will be responsible for ensuring that our products meet the highest regulatory standards.Key Responsibilities:Develop and implement effective RA CMC...

  • CMC Director

    2 months ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    About the Role:Mundipharma International is seeking a highly skilled CMC Director to lead our Regulatory Affairs team in delivering high-quality products to the market. As a key member of our team, you will be responsible for ensuring that our products meet the highest regulatory standards.Key Responsibilities:Develop and implement effective RA CMC...

  • Regulatory Affairs Associate

    5 months ago

    Cambridge, Canada Clarion Medical Technologies Inc. Full time

    The successful applicant will: - Responsible for the maintenance and continual improvement of the company’s quality systems (ISO 13485:2016, MDSAP (FDA/Canada), EU (MD). - Communicate with regulatory agencies regarding potential regulatory pathways, compliance requirements, or clarification and follow-up of regulatory filings or submissions under...

  • Vice President, Legal Affairs and Risk Management

    3 weeks ago

    Cambridge, Ontario, Canada Cowan Insurance Group Full time

    About the RoleWe are seeking a highly skilled and experienced Vice President, Legal Affairs and Risk Management to join our team at Cowan Insurance Group. As a key member of our Executive Leadership Team, you will be responsible for providing strategic legal and risk management advice to our organization.Key ResponsibilitiesProvide legal advice and guidance...

  • Regulatory Policy, Vice President

    2 months ago

    Cambridge, Canada Cowan Insurance Group Full time

    Reporting directly to the President and COO, the VP Legal Affairs and Risk Management is a key member of the Executive Leadership Team and will have responsibilities for both PHL and our operating company, Cowan Insurance Group (“CIG”) Assistance with Fund manager due diligence, document review, compliance etc.Legal matters re owned...

  • Vice President, Legal Affairs and Risk Management

    1 month ago

    Cambridge, Ontario, Canada Cowan Insurance Group Full time

    About the RoleWe are seeking a highly skilled and experienced Vice President, Legal Affairs and Risk Management to join our team at Princeton Holdings. As a key member of the Executive Leadership Team, you will be responsible for providing strategic legal advice and guidance on risk management matters across our organization.Key ResponsibilitiesProvide legal...