Lead Associate, Regulatory Affairs

TalentSphere Staffing Solutions; Richmond; On-site; CAD 85,000 - 90,000; Full time

Job summary

A leading organization in diagnostic innovation is seeking a Lead Associate in Regulatory Affairs. This role focuses on developing regulatory strategies and ensuring compliance for transformative diagnostic products. Candidates should have extensive IVD experience, a regulatory certification, and a passion for collaborative work in a fast-paced environment.

Benefits

Health and dental benefits

Paid sick days

Birthday off

Free parking

On-site gym

Dynamic workplace culture

Qualifications

• 5+ years demonstrated Regulatory Affairs experience in the IVD industry.
• Expert knowledge of global regulatory requirements (FDA, Health Canada, EU IVDR).
• Experience in preparing regulatory submissions and managing compliance.

Responsibilities

• Develop and execute regulatory strategies for new product launches.
• Manage regulatory submissions (FDA 510(k), Health Canada, IVDR).
• Train and mentor team members on regulatory compliance.

Skills

Strong communication skills

Detail-oriented

Problem-solving skills

Organizational skills

Education

Bachelor’s degree in life sciences, engineering, or a related field

RAC certification (Devices)

Tools

Microsoft Office

Adobe tools

Job description

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

• 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 demonstratedRegulatory 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

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, [e-mail]. To apply, please use the TalentSphere job board.

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Job Posting ID:#16648716