Manager, Regulatory Affairs

bioLytical is hiring an experienced Regulatory Affairs (RA) Manager. You will be responsible for defining and implementing regulatory strategies to obtain global approvals for new/modified devices 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 US FDA, Health Canada and international Health Authorities. The Regulatory Affairs Manager is responsible for all product licensing and registration, medical device reporting, reviewing customer complaints, post-market surveillance, product labeling, and permissible marketing communication.

HOW YOU WILL CONTRIBUTE

• Working closely with Executive Management, Sales and Marketing and Scientific Affairs to develop the regulatory strategy to gain market approval for new or modified devices consistent with corporate objectives

• Leading the preparation of complex submissions including PMAs, 510(k)s, PMA Supplements, Design Dossiers (CE), Change notifications, Health Canada license applications and amendments, Renewals and Annual Reports, WHO prequalification submissions and change notifications. All other regulatory submissions to concerned International Competent Authorities

• Conducting/overseeing regulatory assessments for all document, product, and process changes to ensure that change notifications to regulatory bodies are appropriately submitted

• Conducting/overseeing medical device event reporting and complaint handling in accordance with regulations along with post-market surveillance activities

• Participating in designing, reviewing and approving product support internal studies and clinical evaluations

• Ensuring product labeling and promotional materials are compliant with regulations

• Ensuring all national registrations, licenses, listing, and other certifications are maintained as required for regulatory compliance

• Maintaining a good working relationship by interacting proactively and persuasively with global regulatory agencies to gain approvals

• Guiding product development teams in developing new products compliant with Design Control regulations for each applicable regulatory jurisdiction

• Participate in risk assessment of the device and usability

• Ensuring clinical studies are designed and executed in full compliance to GCP, ICH, and pertinent global regulations

• Ensuring the promotion of awareness of regulatory requirements throughout the organization

• Stay up-to-date with regulatory requirements for US FDA, Health Canada, European CE marking, World Health Organization, Australia Therapeutic Goods Administration, and rest of the world (as applicable). Actively review new regulatory requirements to maintain proficiency in worldwide regulations and communicate pertinent information.

• Responsible for developing and meeting regulatory timelines and budgets

WHAT YOU WILL BRING

• Bachelor or Master’s degree in a scientific or engineering discipline, or equivalent combination of education and experience

• A minimum of 5 years of work experience in medical device/IVD compliance and regulatory

• In-depth knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971

• Regulatory Affairs Certification strongly preferred

• Strategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory arguments

• Superior analytical, problem solving and reviewing skills

• Must be able to deliver results on schedule in a fast-paced, dynamic environment

• Excellent prioritization, organizational and project management skills

• Effective written & verbal communication and technical documentation skills

• Excellent computer skills (MS Office, Access, Excel)

• Able to operate independently with minimal direction

• Excellent interpersonal skills

• Flexible and adaptable to take on additional responsibilities as appropriate

WHAT WE OFFER

• A competitive compensation package

• Extended health benefits including dental - 100% employer contribution

• Flexible working hours

• Paid sick days

• Bonus day off with pay on your birthday every year!

• Full-size in-house fitness gym and shower facilities

• Complimentary reserved parking

• Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun

• A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques

• The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table

The annual base salary for this job ranges from:

$90,000-$100,000

bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization.

About bioLytical

bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail’s Fastest Growing Companies list in 2020. We have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year and have been featured on BC’s Fastest Growing Companies six years in a row. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team.

Our full suite of INSTI tests is greater than 99% accurate and have a world-wide footprint of regulatory approvals including US FDA, Health Canada, World Health Organization Prequalification and CE mark for Europe. bioLytical markets its HIV point-of-care tests, HIV self-tests, dual HIV/Syphilis Multiplex point-of-care tests, HCV/Hep B point-of-care tests globally. With a strong product pipeline from our research team, we are developing innovative solutions to tackle some of the world’s most concerning health issues, including Triplex and other Combo tests for various infectious diseases.

CORE VALUES

INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.

NEVER SAY NEVER : Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.

SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.

TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.

INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.

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