Regulatory Affairs Manager

1 month ago

Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time
Job Title: Senior Manager, Regulatory Affairs

Our client, a commercial stage diagnostics company, is seeking a Senior Manager, Regulatory Affairs to join their team. As a key member of the organization, you will be responsible for working directly with the Global Head of Product R&D and external regulatory consultants on FDA 510(k) submissions for current and future in vitro diagnostics (IVD) applications within their autoimmune diagnostics portfolio.

Key Responsibilities:
  • Develop and execute global regulatory plans to obtain clinical and commercial approvals for new products and existing product changes.
  • Lead and support US and global health agency meetings, health agency inquiries, and global filing activities.
  • Support IVD design and development activities, quality compliance activities, and documentation reviews.
  • Perform regulatory reportability assessments and stay abreast of changes in device-related standards and guidance.
  • Develop internal best practices and lead process improvement activities in close collaboration with business leaders.
  • Support IVD supplier engagement and due diligence activities; review regulatory information in quality and supply agreements with partners and suppliers.
  • Work closely with R&D, product development, and operations teams to ensure regulatory compliance throughout development and production.
Requirements:
  • M.Sc. degree or equivalent with 10 or more years of regulatory experience in the diagnostics or medical device industries.
  • Strong knowledge and experience with US FDA regulatory applications, ongoing reporting requirements, concepts, and methods.
  • A solutions-oriented focus to addressing and overcoming regulatory challenges that seeks to minimize time to market and maximize patient access.
  • Previous experience in leading, drafting, and submitting an IVD 510(k) application with the US FDA.
  • Previous experience leading regulatory submissions and reporting outside the United States, including CE mark, UKCA, and Health Canada applications.
  • Local market knowledge with developed network of contacts with CROs, CMOs, and regulatory bodies.
  • RAPS RAC for Canada and US and RAC-Devices will be considered an asset.
  • ISO 13485 knowledge and experience will be considered an asset.
What We Offer:
  • Proximity to SkyTrain and bike routes
  • Free parking near by
  • Teambuilding Company Events
  • Extended Healthcare Benefits
  • Flexible schedule
  • On-site gym
  • Professional Development Support

Please note that the candidate must have legal authority to work in Canada.

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