Sr. Manager, Regulatory Affairs

Augurex Life Sciences Corp.; Vancouver; On-site; CAD 80,000 - 120,000; Full time

Job summary

An established industry player in diagnostics is seeking a Sr. Manager of Regulatory Affairs to lead FDA submissions and enhance regulatory capabilities. This role is pivotal in navigating complex regulatory landscapes for innovative diagnostic tools, ensuring compliance and facilitating market access. Join a passionate team dedicated to transforming healthcare through cutting-edge technology and personalized patient care. The ideal candidate will have extensive experience in regulatory affairs, particularly within the IVD space, and will thrive in a collaborative environment. This is a unique opportunity to make a significant impact in a forward-thinking organization focused on improving patient outcomes.

Benefits

Proximity to SkyTrain and bike routes

Free parking nearby

Teambuilding Company Events

Extended Healthcare Benefits

On-site gym

Professional Development Support

Qualifications

• 10+ years of regulatory experience in diagnostics or medical devices.
• Strong knowledge of FDA regulatory applications and reporting requirements.

Responsibilities

• Develop and execute global regulatory plans for product approvals.
• Lead and support US and global health agency meetings and inquiries.

Skills

Regulatory Affairs

FDA 510(k) submissions

IVD applications

ISO 13485

Communication skills

Teamwork

Education

M.Sc. degree

Tools

MS Office Suite

Adobe Acrobat

Job description

Augurex is a commercial stage diagnostics company dedicated to the early identification and diagnosis of autoimmune disorders, allowing treatment options to be optimized and personalized for patients around the world. Augurex’s lead diagnostic test, JOINTstat, is an important tool in the diagnosis and management of inflammatory diseases, including rheumatoid arthritis, lupus and other autoimmune conditions. SPINEstat expands Augurex’s biomarker-informed diagnostic portfolio into axial spondyloarthritis (axSpA) and has the potential to bring a novel first-in-class diagnostic to this area of significant unmet medical need.

WHY WORK WITH US

At Augurex, we’re a close-knit, passionate team that genuinely cares about making a difference in people’s lives. From the laboratory bench through to clinical development and commercialization, we are building an organization based on our values and a commitment to transform illness into wellness.

SUMMARY

We are seeking a Sr. Manager, Regulatory Affairs to be responsible for working directly with our Global Head of Product R&D and external regulatory consultants on the FDA 510(k) submission for SPINEstat as well as future in vitro diagnostics (IVD) applications within our autoimmune diagnostics portfolio. The successful candidate brings a solutions-oriented mindset and will lead various elements of the FDA submissions process and will play an important role in championing and managing both new and existing regulatory applications, including CE mark, UKCA and Health Canada applications. The successful candidate will also lead ad-hoc or special projects that advance our product expansion strategies, or which continuously improve or otherwise advance our regulatory capabilities. This individual is a detail-oriented team player, with demonstrated experience in regulatory affairs within the IVD or medical devices industry.

ROLE AND RESPONSIBILITIES

• In a matrix management environment with internal stakeholders and leveraging external consultants, 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 (e.g. design controls and human factors), 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 the 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.
• Promote a culture of regulatory awareness and compliance within the organization, while embodying an entrepreneurial, flexible, growth mindset.

QUALIFICATIONS AND EXPERIENCE

• 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.

BENEFITS

• Proximity to SkyTrain and bike routes
• Free parking near by
• Teambuilding Company Events
• Extended Healthcare Benefits
• On-site gym
• Professional Development Support

For questions regarding this opportunity and application process, please contact Carla Campbell, Executive Talent Consultant, Life Sciences at [e-mail] or at 1-778-807-9777 ext738.