Manager, Regulatory Affairs
7 days ago
Location: Greater Vancouver On-Site
Reporting to: Director
Salary Range: $90,000 to $120,000 per annum
Position Overview:
A growing organization in the medical diagnostics sector is seeking a Manager, Regulatory Affairs (IVD) to lead regulatory projects, ensure compliance with global requirements, and support product registrations across multiple jurisdictions. This role involves managing cross-functional teams, mentoring junior staff, and developing regulatory strategies to achieve market access for innovative IVD products.
Key Responsibilities:
- Regulatory Leadership:
- Lead preparation and submission of global regulatory filings (e.g., De Novo, PMA, 510(k)).
- Act as the primary liaison with regulatory agencies.
- Compliance & Strategy:
- Develop and implement strategies to meet global standards (FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA, etc.).
- Monitor regulatory changes to assess impacts on products.
- Collaboration & Mentorship:
- Partner with R&D, Quality, and Operations teams to ensure market readiness.
- Mentor junior staff and review work for compliance.
- Process Improvement:
- Optimize regulatory workflows and documentation processes.
Qualifications:
- Education: Bachelor’s in Life Sciences, Biotechnology, or related field (advanced degree preferred).
- Experience:
- 8+ years in Regulatory Affairs, focusing on IVDs or medical devices.
- Proven experience with global submissions (e.g.,
- De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia).
- Skills:
- Strong understanding of global regulatory standards.
- Exceptional organizational, problem-solving, and communication skills.
- Authority to work in Canada.
What’s Offered:
This is an exciting opportunity to join a dynamic organization driving impactful diagnostic solutions.
To Apply:
For a full job description contact Carla Campbell, Executive Talent Consultant, TalentSphere – Life Sciences, at ccampbell@talentsphere.ca. To apply, please use the TalentSphere job board.
TSSHP LI-TS1
Job Posting ID: #16567019
-
Lead Associate, Regulatory Affairs
3 weeks ago
Richmond, Canada bioLytical Full time**bioLytical** is hiring an demonstrated Regulatory Affairs (RA) Associate. You will actively support operations for the market entry of new IVD products and the maintenance of licenses for commercially marketed products. You will share your expertise and help train team members. As a RAC certified professional with US FDA experience, you play a vital role...
-
Regulatory Affairs Lead
1 hour ago
Richmond, British Columbia, Canada TalentSphere Staffing Solutions Full timeJob SummaryWe are seeking a seasoned Regulatory Affairs professional to lead regulatory projects, ensure compliance with global requirements, and support product registrations across multiple jurisdictions.Key ResponsibilitiesRegulatory Leadership:Prepare and submit global regulatory filings (e.g. FDA, EU IVDR) and serve as primary liaison with regulatory...
-
Regulatory Consumer Affairs Director
2 weeks ago
Richmond, British Columbia, Canada Natures Path Foods Full timeKey Responsibilities:This role is a key part of Natures Path Foods' success in the food industry. The Regulatory Consumer Affairs Manager will be responsible for ensuring that all products comply with regulatory requirements and maintain high-quality standards.Regulatory Compliance: Serve as the subject matter expert on regulatory compliance, labeling, and...
-
Regulatory Affairs Associate
6 months ago
Richmond, Canada bioLytical Full time**bioLytical** is hiring a diligent Regulatory Affairs (RA) Associate. You are responsible for executing regulatory tasks related to maintenance of current product licenses, obtaining approvals for new or modified products and conducting regulatory assessments for any QMS related activities meeting bioLytical’s corporate objectives. You will play a vital...
-
Associate Ii, Regulatory Affairs
3 weeks ago
Richmond, Canada bioLytical Full time**bioLytical** is hiring an experienced Regulatory Affairs (RA) Associate. You are responsible for executing regulatory tasks related to obtaining approvals for new or modified products and maintaining existing product registrations to meet bioLytical’s corporate objectives. You will play a vital role in driving forward our mission to get people tested...
-
Director of Quality Assurance and Regulatory Affairs
2 months ago
Richmond, Canada Nature's Path Full timeh3>Regulatory Consumer Affairs Manager (hybrid in Richmond)Job Category: Quality AssuranceRequisition Number: REGUL002078Posted: August 23, 2024Full-TimeLocationsNature's Path Foods9100 Van Horne WayRichmond, BC V6X1W3, CANIn a nutshell this role is: Customer/Consumer Complaints response and trending 20%, Certification compliance 30%, Label compliance 30%,...
-
Regulatory Consumer Affairs Manager
3 months ago
Richmond, Canada Nature's Path Foods Full time**Key responsibilities**: - Set the labeling standards and guidelines for all products in all country of sale. - Act as an advocate for customer regulatory issues regarding label compliance. - Identify, manage, and implement process improvements as it relates to the management of regulatory information. - Respond to internal and external customer product,...
-
Corporate Affairs and Hse Manager
3 weeks ago
Richmond, Canada Graymont Full time**Job Introduction**: Graymont is seeking a driven Corporate Affairs and HSE Manager to lead impactful strategies across the Western North American Region, partnering with plant managers and leaders to drive continuous improvement in HSE programs at Graymont. Canada - BC - Richmond Reporting to the Director, Corporate Affairs, Environment, & Sustainability...
-
Public Affairs Intern
7 months ago
Richmond, Canada Paper Excellence Full timeAbout Paper Excellence: Paper Excellence is a leading pulp and paper producer, headquartered in Canada, with operations in North America and Europe. With a commitment to sustainability and innovation, Paper Excellence is focused on delivering high-quality products while minimizing its environmental impact. The company is dedicated to supporting the...
-
Associate, Regulatory Affairs
3 days ago
Richmond Hill, Canada APOTEX Full timeAbout Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the...
-
Regulatory Compliance Specialist
3 weeks ago
Richmond, British Columbia, Canada Natures Path Foods Full timeAbout the Role: We are looking for a highly skilled Regulatory Consumer Affairs Manager to join our team at Natures Path Foods. The successful candidate will be responsible for ensuring compliance with regulatory requirements, labeling and claims, and providing consumer services. Key Responsibilities: Serve as the Subject Matter Expert (SME) for...
-
Associate, Regulatory Affairs
3 days ago
Richmond Hill, Canada APOTEX Full timeAbout Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the...
-
Manager Clinical Affairs
5 months ago
Richmond Hill, Canada Prollenium Medical Technologies Inc. Full timeCOMPANY OVERVIEW:Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium HA dermal filler. We are proud to address all of our client's needs through streamlined medical device innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline of...
-
Head of Marketing and Public Affairs
6 months ago
Richmond, Canada Harbour Air Group Full time**NOW HIRING - Head of Marketing & Public Affairs** **The Head of Marketing & Public Affairs plays a pivotal role in developing and executing comprehensive marketing and public affairs strategies that align with our business objectives, supports revenue generation, and ensures effective communication with key stakeholders. This role is responsible for...
-
Manager Clinical Affairs
5 months ago
Richmond Hill, Ontario, York region, Canada Prollenium Medical Technologies Inc. Full timeCOMPANY OVERVIEW:Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium HA dermal filler. We are proud to address all of our client's needs through streamlined medical device innovation. Prollenium is able to ensure a continual flow of creation, unique ideas, and a steady pipeline...
-
English Language Manager
3 days ago
Richmond, Canada TalentSphere Staffing Solutions Full timeManager, Regulatory Affairs (IVD) – CONFIDENTIAL SEARCHLocation: Greater Vancouver On-SiteReporting to: DirectorSalary Range: $90,000 to $120,000 per annumPosition Overview:A growing organization in the medical diagnostics sector is seeking a Manager, Regulatory Affairs (IVD) to lead regulatory projects, ensure compliance with global requirements, and...
-
Clinical and Medical Affairs Director
2 hours ago
Richmond Hill, Canada Prollenium Medical Technologies Inc. Full timeJob Title: Clinical and Medical Affairs DirectorAbout Us:Prollenium Medical Technologies Inc. is a fast-growing Canadian developer, manufacturer, and international distributor of premium HA dermal fillers.We are dedicated to innovation, addressing all our client's needs through streamlined medical device development. Our unique approach ensures a steady...
-
Board Affairs Coordinator
6 months ago
Richmond Hill, Canada Open Text Corporation Full time**Board Affairs Coordinator**: - Req id: 36426- Richmond Hill, ON, CA**OPENTEXT - THE INFORMATION COMPANY** As the Information Company, our mission at OpenText is to create software solutions and deliver services that redefine the future of digital. Be part of a winning team that leads the way in Enterprise Information Management. **The...
-
Regulatory Affairs Coordinator
3 weeks ago
Richmond, Canada Nature's Path Foods Full time**Critical Outcomes of the Job**: - Develop label copy, and evaluate packaging and product formulations to ensure the correct labelling of new and existing products against the appropriate regulations, guidelines, internal labelling standards and policies - Review and approve artwork circulations - Remain current on all company labelling standards and...
-
Regulatory Compliance Specialist
2 weeks ago
Richmond, British Columbia, Canada Nature's Path Full timeWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Nature's Path Foods in Richmond, BC. As a key member of our Quality Assurance department, you will be responsible for ensuring that our products comply with all relevant regulations and standards.Job SummaryThis is a hybrid opportunity based out of our Richmond, BC...