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Regulatory Affairs Specialist

Regulatory Affairs Specialist

TalentSphere Staffing SolutionsEdmonton, AB, Canada
2 days ago
Salary
CA$70.00–CA$120.00 hourly
Job type
  • Full-time
  • Permanent
Job description

Job Title : Regulatory Affairs Specialist - MedTech

Head Office :  Edmonton, AB

Working Arrangement :  This position offers flexibility with options for hybrid (combination of in-office and remote) or fully remote work.

Position : Permanent, Full-Time

Reporting to : Director, Commercial Operations

Salary Range : $80,000 - $120,000

Ready to Make a Difference? Step into a Role That Shapes the Future of Medical Innovation – Apply Now and Let Your Expertise Drive Global Impact!

We are seeking an experienced Regulatory Affairs Specialist to provide strategic guidance and support for regulatory compliance and submissions related to medical devices. This role focuses on both software and hardware-based devices, ensuring compliance with Health Canada and FDA regulations. The successful candidate will develop regulatory strategies, lead submissions, and mentor junior staff while collaborating with cross-functional teams to support clients' regulatory needs.

Key Responsibilities :

  • Serve as the primary regulatory point of contact for clients, guiding them through regulatory pathways.
  • Prepare and manage regulatory submissions for medical devices (e.g., SaMD and hardware).
  • Ensure compliance with Health Canada and FDA regulations, including ISO 13485 standards.
  • Conduct regulatory assessments, gap analyses, and document reviews.
  • Mentor junior staff and foster a collaborative team environment.

Qualifications :

  • Bachelor’s degree in a relevant field (Master’s preferred).
  • Regulatory Affairs Certification (RAC) is an asset.
  • Minimum of 5 years of experience in regulatory affairs for medical devices, including software and hardware products.
  • Proven expertise with Health Canada and FDA submissions (e.g., MDL, ITA, 510(k), PMA).
  • Strong knowledge of medical device regulations, design controls, and post-market surveillance.
  • Excellent communication, problem-solving, and project management skills.
  • And, must have the authority to work in Canada.

    • Perks and Benefits :

  • Extended health benefits
  • Professional development.
  • Transit allowance

    • This role offers a dynamic opportunity to contribute to the success of innovative medical devices while advancing your career in regulatory affairs.

    TSSHP LI-TS1

    Job Posting ID :  (#16576103)