Title: Lead Associate, Regulatory Affairs (IVD)
Location: Greater Vancouver On-Site
Position: Permanent, Full-Time 
Workplace Type: On-site
Reports To: Manager
Salary Range: $85,000 to $90,000 per annum

Your regulatory know-how + our innovative tech = global health breakthroughs

Position Overview:

Step into a high-impact Lead Associate, Regulatory Affairs role where your expertise will help shape the future of diagnostic innovation. With your strong IVD background and RAC certification, you’ll play a critical role in driving global market access for transformative diagnostic products. You'll ensure regulatory compliance across jurisdictions and champion a culture of excellence and continuous improvement. If you're passionate about translating complex requirements into clear, strategic pathways—and thrive in a collaborative, fast-paced environment—this is your chance to make a meaningful impact.

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Key Responsibilities

    Regulatory Strategy & Submissions

•  Develop and execute global regulatory strategies to support new product launches and changes.
•  Prepare and manage submissions (FDA 510(k), De Novo, Health Canada, IVDR, WHO PQ, TGA).
•  Evaluate product modifications for regulatory impact and ensure proper classification.

    Compliance & Risk Management

•  Maintain establishment licenses and product registrations across jurisdictions
•  Review and approve labelling, IFUs, and marketing materials for compliance.
•  Act as RA SME during audits and inspections; manage regulatory CAPAs.
•  Track global regulatory updates and assess business impact.

    Collaboration & Mentorship

• Partner with cross-functional teams (R&D, QA/QC, Clinical, Marketing) to guide regulatory decisions.
• Represent RA in meetings with regulatory authorities and internal stakeholders.
• Train and mentor team members, promoting best practices and compliance awareness.

Qualifications

    Education & Certification

• Bachelor’s degree in life sciences, engineering, or a related field.
• RAC certification (Devices) is a preferred.

    Experience & Knowledge

•  5+ years demonstrated Regulatory Affairs experience specifically in the IVD industry.
•  In-depth expert knowledge of global regulatory requirements, including FDA (510(k), De Novo), Health Canada, EU IVDR, WHO, and TGA.
• Experience preparing and managing regulatory submissions and license maintenance.

    Skills & Abilities

•  Strong communication skills, with the ability to interact confidently with regulatory agencies and internal teams.
•  Detail-oriented with strong problem-solving and organizational skills.
•  Proficient with Microsoft Office and Adobe tools.
• 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

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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
LI-TS1
Job Posting ID: #16567017

Thank you for your interest in this job posting.

We look forward to hearing from you.

TalentSphere Staffing Solutions
talentsphere.ca

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