Manager, Regulatory

At bioLytical , we don’t just develop rapid diagnostics—we transform access to healthcare by getting accurate results into hands and lives that need them most. We’ve built a reputation for innovation, speed, and quality. Now, we’re looking for a Manager, Regulatory who sees regulatory strategy and clinical research as a powerful launchpad for global health impact.

This role goes beyond traditional regulatory submission management. You’ll own the full regulatory lifecycle , lead the charge on international registrations, and bring the clinical vision to life—from protocol development to real-world validation. You’ll be at the intersection of product development, global approvals, and clinical credibility—guiding our diagnostics from concept to clinic, from Canada to the world.

Apply today if you’re ready to lead boldly, learn constantly, and own the path that gets diagnostics into the hands of people who need them.

WHAT YOU’LL OWN

Regulatory Leadership

• Define, shape, and execute global regulatory strategies that accelerate time-to-market and maximize patient access.

• Lead the preparation of high-impact submissions (FDA 510(k), PMA, CE Marking, Health Canada, WHO PQ and more), and keep our innovation pipeline compliant, agile, and moving forward.

• Take full ownership of post-market responsibilities—from medical device reporting to labeling compliance and global license renewals.

• Partner cross-functionally to ensure every product and change is navigated with regulatory foresight and confidence.

WHAT YOU WILL BRING

• Background in science or engineering, ideally with a Bachelor’s or Master’s in Biological Sciences, Biomedical Engineering, or a related field.

• 5+ years of hands-on experience in regulatory affairs in medical devices or diagnostics.

• A working knowledge of FDA, Health Canada, ISO 13485, ISO 14971, CE Marking , and global medical device frameworks.

• Exceptional analytical and communication skills, able to distill complex technical data into regulatory arguments that win.

• You know how to design a study, write a protocol, monitor a site, and own the clinical lifecycle—from ethics to final report.

• You’re collaborative, organized, and bring calm to fast-moving environments.

• Strong writer and communicator—across submission documents, presentations, and team updates.

• Asset if you hold a Regulatory Affairs Certification (RAC) and are familiar with GCP, ICH, and WHO PQ.
  

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 is a rapidly growing biomedical company. The company’s vision is to develop innovative rapid diagnostic test to help fight several diseases around the world. The company aims to be vertically integrated, producing in house all the materials required for the testing device, from recombinant protein production to the final kit. Thus, bioLytical is looking for people eager to build and help shape the company of the future.

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.

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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