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Regulatory Affairs Director

2 months ago

Vancouver, British Columbia, Canada TalentSphere Staffing Solutions Full time
About the Role

We are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team at Augurex Life Sciences. As a key member of our regulatory team, you will be responsible for developing and executing global regulatory plans to obtain clinical and commercial approvals for new products and existing product changes.

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.
  • Superior computer proficiency (MS Office Suite, Adobe Acrobat or equivalent); aptitude and desire to learn new computer applications.
  • Exceptional communication and teamwork skills.
  • Collaborative worker with an ability to support a high-performing team, be a problem-solver, with a positive attitude, and able to work in a dynamic environment.
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.