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
Position Overview:
Drive Diagnostic Innovation – Join Us as a Regulatory Affairs Associate!
Take your 2+ years of Regulatory Affairs experience in Medical Devices to the next level. As a Regulatory Affairs Associate, your expertise in regulatory pathways and attention to detail will help bring innovative 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 2+ years of experience in Regulatory Affairs and Quality Assurance within the Medical Device 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
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: #16666759
