Regulatory Affairs Associate - IVD

TalentSphere Staffing Solutions; Richmond; On-site; CAD 50,000 - 60,000; Full time

Job summary

Join a leading company as a Regulatory Affairs Associate in Greater Vancouver, where you'll leverage your 3+ years of experience in Regulatory Affairs to drive innovation in diagnostic technology. You'll manage regulatory submissions, ensure compliance with global standards, and collaborate with cross-functional teams to launch cutting-edge IVD products. Enjoy a competitive salary, flexible hours, and comprehensive benefits while working in a dynamic, supportive environment.

Benefits

Competitive Salary & 100% Employer-Paid Benefits

Flexible Hours & Paid Sick Days

On-Site Gym & Reserved Parking

Company Events & Summer BBQs

Qualifications

• 3+ years of experience in Regulatory Affairs within the Medical Device or IVD industry.
• Regulatory Affairs Certification (RAC - Devices) is considered an asset.

Responsibilities

• Prepare and manage regulatory submissions including 510(k)s and PMA supplements.
• Lead regulatory activities for global markets including Asia and Africa.
• Develop regulatory strategies for new product launches.

Skills

Communication

Attention to Detail

Analytical Abilities

Project Management

Education

Bachelor’s degree in Life Sciences

Bachelor’s degree in Engineering

Tools

Microsoft Office Suite

Adobe Professional

Job description

Title:Regulatory Affairs Associate (IVD)
Location: Greater Vancouver On-Site
Position: Permanent, Full-Time
Workplace Type: On-site
Reports To: Manager
Salary Range:$50,000 to $60,000 per annum

Your Passion for Compliance + Our Cutting-Edge Tech = Launching Tomorrow's Diagnostics Today!

Position Overview:

Drive Diagnostic Innovation – Join Us as a Regulatory Affairs Associate!

Take your 3+ years of Regulatory Affairs experience to the next level with a team dedicated to advancing diagnostic technology. As a Regulatory Affairs Associate, your expertise in regulatory pathways and attention to detail will help bring innovative IVD products to global markets.If you are ready to grow your expertise in a fast-paced, innovative environment, this is your opportunity to make an impact.

Regulatory Affairs Associate – Driving Global IVD Compliance

Our client is seeking a committed Regulatory Affairs (RA) Associate to support the development and market entry of innovative IVD products. In this role, you will help maintain global regulatory compliance, manage product licenses, and collaborate with cross-functional teams to ensure seamless product launches. Your contributions will be key in bringing advanced diagnostic technologies to market.

Key Responsibilities:

• Regulatory Submissions & Documentation:

  • Prepare and manage regulatory submissions, including 510(k)s, PMA supplements, Health Canada MDLs, and Notified Body submissions.

  • Compile and submit change notifications, amendments, and initial applications for new and existing products.

  • Ensure all documentation aligns with the regulatory requirements of US FDA, Health Canada, Notified Bodies, WHO, and other international authorities.

• Global Market Registrations:

  • Lead regulatory activities for Rest-of-the-World (ROW) markets, including Asia, Africa, Latin America, and WHO-regulated territories.

  • Facilitate document authentication and legalization, provide routine project updates, and coordinate with international business partners.

• Regulatory Strategy Development:

  • Develop and implement regulatory strategies for new product launches and market expansions.

  • Analyze regulatory pathways to ensure timely and efficient market entry.

• Compliance & Reporting:

  • Assess customer complaints for regulatory reporting of adverse events and manage Medical Device Reports (MDRs) as required.

  • Conduct reviews of marketing and sales materials for compliance with global regulations and company policies.

• Regulatory Intelligence & Communication:

  • Monitor global regulatory changes and communicate key updates to internal teams.

  • Maintain proactive relationships with global regulatory agencies to facilitate approvals.

• Audit & Quality Support:

  • Participate in internal audits and support external certification audits by providing key regulatory documentation and expertise.

  • Ensure accurate and organized regulatory record-keeping for compliance verification.

Key Requirements:

• Education:

  • Bachelor’s degree in Life Sciences, Engineering, or a related field.

• Experience:

  • Minimum of 3+ years of experience in Regulatory Affairs within the Medical Device or IVD industry.

  • Proven track record of preparing and managing regulatory submissions and license applications.

• Certifications:

  • Regulatory Affairs Certification (RAC - Devices) is considered an asset.

• Technical Skills:

  • Knowledge of US FDA, Health Canada, EU IVDR, and Australian regulations for medical devices and IVDs.

  • Strong proficiency with Microsoft Office Suite and Adobe Professional.

• Soft Skills:

  • Excellent communication skills for effective regulatory correspondence.

  • High attention to detail and analytical abilities to interpret complex information.

  • Ability to manage multiple projects in a fast-paced environment with strict deadlines.

What We Offer:

• Competitive Salary & 100% Employer-Paid Benefits

• Flexible Hours & Paid Sick Days

• On-Site Gym & Reserved Parking

• Work with Industry Experts – passionate, driven, and fun

• Company Events & Summer BBQs – join the fun and celebrate with the team.

Ready to drive innovation in diagnostics while enjoying a workplace that values passion and fun? Join us!

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.

TSSHP LI-TS1
LI-TS1
Job Posting ID:#16666759