Manager, Regulatory Affairs - IVD

TalentSphere Staffing Solutions; Vancouver; On-site; CAD 90,000 - 100,000; Full time

Job summary

A staffing solutions firm in Metro Vancouver is seeking a Manager for Regulatory Affairs with over 6 years of IVD experience. The role involves leading regulatory strategies, preparing global submissions for medical devices, and managing a regulatory team. The ideal candidate has a Bachelor’s in Life Sciences, experience with regulatory processes, and proven leadership skills. Attractive benefits and competitive salary are offered.

Benefits

Competitive salary

Health and dental benefits

Paid sick days

Birthday off

Free parking

On-site gym

Dynamic workplace culture

Qualifications

• 6+ years of IVD experience and RAC certification.
• Experience in global submissions for medical devices.
• Authority to work in Canada.

Responsibilities

• Lead regulatory filings and submissions.
• Act as liaison with regulatory agencies.
• Manage a regulatory team and mentor junior staff.
• Monitor regulatory changes impacting products.

Skills

Leadership

Project management

Communication

Regulatory knowledge

Education

Bachelor’s in Life Sciences

Biotechnology, RAC preferred

Job description

Overview

Manager, Regulatory Affairs (IVD) role at TalentSphere Staffing Solutions. Location: Greater Vancouver – On-Site. Employment type: Permanent, Full-Time. Salary Range: $90,000 to $100,000 per annum.

With 6+ years of IVD experience and RAC certification, you will lead regulatory strategies and submissions to support global market approvals for diagnostic medical devices. Responsibilities include preparing submissions (510(k), CE, Health Canada, WHO, etc.), overseeing product licensing, complaint handling, post-market surveillance, labeling, and change notifications. You will manage regulatory staff and collaborate cross-functionally with leadership, product development, and quality teams.

Key Responsibilities

• Lead preparation and submission of global regulatory filings (e.g., De Novo, PMA, 510(k))
• Act as the primary liaison with regulatory agencies
• Management and mentor a regulatory team
• Develop and implement strategies to meet global standards (FDA, EU IVDR, Health Canada, PMDA, NMPA, HAS and TGA, etc.)
• Proven leadership, project management, and communication skills
• Monitor regulatory changes to assess impacts on products
• Oversee product licensing, labeling, complaints, and post-market surveillance
• Partner with R&D, Quality, and Operations teams to ensure market readiness
• Mentor junior staff and review work for compliance
• Optimize regulatory workflows and documentation processes

Qualifications

• Education: Bachelor’s in Life Sciences, Biotechnology, RAC preferred
• Experience: Required 5+ years in Regulatory Affairs, with specific experience working in IVDs.
• Proven experience with global submissions (e.g., De Novo, PMA, 510(k)), Canada, Europe (IVDR), Japan, China, Singapore, Australia.
• Proven leadership, project management, and communication skills
• Authority to work in Canada.

Perks

• Competitive salary
• Health and dental benefits, paid sick days, birthday off
• Free parking, on-site gym, and a dynamic workplace culture

What’s Offered

This is an exciting opportunity to join a dynamic organization driving impactful diagnostic solutions.

How to Apply

For a full job description contact Carla Campbell, Executive Talent Consultant, TalentSphere – Life Sciences, at [e-mail]. To apply, please use the TalentSphere job board.