Regulatory Affairs Associate - IVD
Regulatory Affairs Associate - IVD
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Title:Regulatory Affairs Associate (IVD)
Location: Greater Vancouver OnSite
Position: Permanent FullTime
Workplace Type: Onsite
Reports To: Manager
Salary Range:$50000 to $60000 per annum
Your Passion for Compliance Our CuttingEdge Tech Launching Tomorrows 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 you are ready to grow your expertise in a fastpaced 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 crossfunctional 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 RestoftheWorld (ROW) markets including Asia Africa Latin America and WHOregulated 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 recordkeeping for compliance verification.
Key Requirements:
Education:
Bachelors 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 fastpaced environment with strict deadlines.
What We Offer:
Competitive Salary & 100% EmployerPaid Benefits
Flexible Hours & Paid Sick Days
OnSite 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 at. To apply please use the TalentSphere job board.
TSSHP LITS1
LITS1
Job Posting ID:#
Thank you for your interest in this job posting.
We look forward to hearing from you.
TalentSphere Staffing Solutions
Canada
United States
Required Experience:
IC
Employment Type
Full-Time
