Regulatory Affairs Manager Location: Richmond, BC, Canada Department: Regulatory Affairs Position: Permanent, Full-Time ______________________________________________________________________________ ABOUT BIOLYTICAL bioLytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian Company federally incorporated in 2002 and focused on the research, development and commercialization of rapid, point-of-care in vitro medical diagnostics developed using its proprietary INSTI™ technology platform. Today, the company sells and markets its INSTI™ HIV test and has a world-wide footprint of regulatory approvals including US FDA approval, Health Canada approval and CE mark. Our product provides a highly accurate HIV test result in as little as 60 seconds which translates into a compelling value proposition for patients, healthcare professionals, and public health organizations. SUMMARY Reporting to the Chief Technical Officer, the Regulatory Affairs Manager is responsible for defining and implementing regulatory strategies to obtain global approvals for new/modified devices and combination products in order to meet bioLytical’s corporate objectives. This role requires the ability to analyze complex technical and medical information and formulate strong regulatory arguments that can be defended with regulatory agencies such as the FDA and international Health Authorities. The Regulatory Affairs Manager must also ensure compliance with global regulations for design controls, cGMP, facility registration, device listing, licenses, safety reporting, complaints, clinical trial requirements, post-market surveillance, labeling, and permissible marketing communication. The Regulatory Affairs Manager is the head of the RA department and seen as one of bioLytical’s leaders in moving the company to the next level of performance. ROLE AND RESPONSIBILITIES  Work closely with Senior Management, Sales and Marketing, R&D and Clinical Affairs to develop the regulatory strategy in order to gain market approval for new or modified devices/combination products consistent with corporate objectives  Lead the preparation of complex submissions including PMAs, 510(k)s, Notified Body/Competent Authority application, Health Canada licenses, WHO and submissions to other international Competent Authorities  Maintain a good working relationship by interacting proactively and persuasively with global regulatory agencies in order to gain approvals  Guide product development teams in developing new products in accordance with Design Control regulations  Ensure clinical studies are designed and executed in full compliance to GCP, ICH, and pertinent global regulations         Provide oversight of regulatory assessments for all document, product, and process changes to ensure that change notifications to regulatory bodies are appropriately submitted Ensure product labeling and promotional materials are compliant with regulations Ensure all national registrations, licenses, listing, and other certifications are maintained as required for regulatory compliance Possesses in-depth understanding of US and OUS regulation requirements. Actively review new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicate pertinent information. Responsible for global safety reporting and complaint handling in accordance with regulations Manage regulatory staff and contract and manage specialized regulatory consultants as necessary Accountable for developing and meeting regulatory timelines and budgets Participate as a bioLytical representative during inspections by regulatory agencies QUALIFICATIONS The successful candidate will meet the following criteria:  BA/BS in the life sciences, or engineering with MS preferred  10+ years of regulatory experience in the medical device/pharmaceutical/biologics industry  Experience developing and successfully defending complex regulatory submissions for medical devices (PMA, 510(k)) and combination devices  Experience directly, and successfully, interfacing with the FDA and other regulatory bodies  Experience with Health Canada and international device regulatory submissions required, including EU and other ROW health authorities  5+ years of managerial experience required including direct supervisory experience and experience building and meeting budgets and timelines  Strategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory arguments  Strong project management and problem-solving skills  Regulatory Affairs Certification preferred HOW TO APPLY bioLytical Laboratories Inc offers a challenging, enriching work environment and competitive compensation commensurate with experience. For additional details about this opportunity and to apply, please send a cover letter and resume to [email protected]. We are an equal opportunity employer and invite applications from all qualified individuals.