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.
- 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 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...

  • Regulatory Affairs Manager

    1 month 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...

  • Regulatory Affairs CMC Director

    4 weeks ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    Regulatory Affairs CMC Director£80,000 - £110,000 per annumCambridge (Home working with some travels to Cambridge when needed)Job Description:This is a challenging and rewarding role as CMC Director where you will be responsible for efficiently managing and delivering Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for products across...

  • Director, Regulatory Affairs

    6 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...

  • Regulatory Affairs Associate

    2 weeks ago

    Cambridge, Canada Clarion Medical Technologies 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...

  • Manager Regulatory Affairs

    1 month 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,...

  • Regulatory Affairs Associate

    6 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...

  • Manager Regulatory Affairs

    4 weeks 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, the...

  • Regulatory Affairs Director for Marketed Products CMC

    4 weeks ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    Job DescriptionMundipharma International is seeking an experienced Regulatory Affairs Director to lead the development and implementation of strategies for Chemistry, Manufacturing, and Controls (CMC) in marketed products across EU and ROW.This role requires a strong leader who can collaborate effectively with cross-functional teams, including Technical...

  • Regulatory Affairs Chemistry Manufacturing Control Lead

    3 days ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    Market Leaders in CMC ExpertiseWe are seeking a highly skilled Regulatory Affairs Chemistry Manufacturing Control (RA CMC) professional to lead our team in delivering exceptional outcomes for products across the EU and ROW.This role requires a strategic thinker with strong leadership skills, capable of building and maintaining collaborative partnerships with...

  • Regulatory Compliance Specialist

    4 weeks ago

    Cambridge, Ontario, Canada Clarion Medical Technologies Inc. Full time

    Company Overview:Clarion Medical Technologies Inc. is a leading provider of surgical, vision, and aesthetic healthcare medical devices in Canada.We specialize in laser technologies, diagnostic tools for early disease detection, and advanced imaging systems. Our mission is to empower healthcare providers with the tools and expertise to deliver outstanding...

  • Energy Regulatory Affairs and Revenue Assurance Lead

    4 weeks ago

    Cambridge, Ontario, Canada The MEARIE Group Full time

    Company Overview:GrandBridge Energy Inc. (GBE) is a leading energy transformation company driven by a mission to bridge communities to the energy future. With over 113,000 customers across Brantford, Cambridge, North Dumfries, and Brant, GBE provides safe and reliable electricity while navigating the transition towards a dynamic and evolving energy...

  • Regulatory Affairs CMC Director for EU and ROW Products

    2 weeks ago

    Cambridge, Ontario, Canada Mundipharma International Full time

    Job DescriptionWe are seeking an experienced CMC Director to oversee the Regulatory Affairs Chemistry Manufacturing Control (RA CMC) outcomes for our products across the European Union and Rest of World. This role will involve building and maintaining collaborative relationships with product teams, particularly with members from Tech Ops and Quality.The...

  • Regulatory Compliance Specialist

    4 weeks ago

    Cambridge, Ontario, Canada Clarion Medical Technologies Inc. Full time

    Clarion Medical Technologies, a leading innovator in surgical, vision, and aesthetic healthcare medical devices, offers an exciting opportunity for a Regulatory Compliance Specialist.With a competitive salary of $80,000 - $110,000 per year, this role is perfect for someone with a strong background in regulatory affairs and quality compliance. Located in...

  • Regulatory Policy, Vice President

    3 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...

  • Compliance, Systems and Data Manager

    2 weeks ago

    Cambridge, Canada Casterton Full time

    p>ARA-P3-12Job Title: Regulatory Affairs & Systems Data ManagerLocation: Cambridge (Hybrid/Flexible)Job type: permanentAt Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.The Manager will be...

  • Compliance, Systems and Data Manager

    2 weeks ago

    Cambridge, Canada Casterton Full time

    p>ARA-P3-12Job Title: Regulatory Affairs & Systems Data ManagerLocation: Cambridge (Hybrid/Flexible)Job type: permanentAt Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.The Manager will be...

  • Packaging Compliance Associate

    3 weeks ago

    Cambridge, Canada RDJ Bakeries Full time

    Job Posting: At **_RDJ Bakeries_**_,_ we are a well-established leader in the cracker manufacturing industry, recognized across Canada and globally for our exceptional quality products. Our diverse team reflects our commitment to fostering an inclusive workplace where every voice is valued, and our shared passion for excellence and innovation drives...

  • Packaging Compliance Associate

    1 week ago

    Cambridge, Canada RDJ Bakeries Ltd. Full time

    Job Posting At RDJ Bakeries , we are a well-established leader in the cracker manufacturing industry, recognized across Canada and globally for our exceptional quality products. Our diverse team reflects our commitment to fostering an inclusive workplace where every voice is valued, and our shared passion for excellence and innovation drives everything we...

  • Business Development Associate

    6 days ago

    Cambridge, Ontario, Canada Farm Mutual Re Full time

    Job Title: Business Development AssociateAbout Us: Farm Mutual Re, a leading reinsurer in Canada, is committed to advancing the mutual insurance community. Our team is passionate about empowering and advancing our industry.Company Overview: As a department within Farm Mutual Re, the Ontario Mutual Automobile Plan (OMAP) provides product, underwriting,...