Lead Associate, Regulatory Affairs

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.

Key Responsibilities

Regulatory Strategy & Submissions

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

Compliance & Risk Management

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

Collaboration & Mentorship

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

Qualifications

Education & Certification

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

Experience & Knowledge

1. 5+ years demonstrated Regulatory Affairs experience specifically in the IVD industry.
2. In-depth expert knowledge of global regulatory requirements, including FDA (510(k), De Novo), Health Canada, EU IVDR, WHO, and TGA.
3. Experience preparing and managing regulatory submissions and license maintenance.

Skills & Abilities

1. Strong communication skills, with the ability to interact confidently with regulatory agencies and internal teams.
2. Detail-oriented with strong problem-solving and organizational skills.
3. Proficient with Microsoft Office and Adobe tools.
4. Authority to work in Canada.

Perks:

1. Competitive salary.
2. Health and dental benefits, paid sick days, birthday off.
3. 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.

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.

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Job Posting ID: #16567017