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Regulatory Affairs Manager
1 month ago
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.
- 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.
- 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.
