Job Description

Are you a hands-on, proven leader in compliance looking to make a global impact?


bioLytical is seeking an experienced, strategic Director, Compliance to lead and actively contribute to our global regulatory and quality operations. Reporting directly to the Chief Operating Officer, this dynamic role combines high-level strategy with day-to-day involvement guiding teams, interfacing with global regulatory agencies, and ensuring compliance across all facets of the business.


If you're passionate about advancing healthcare diagnostic assurance and excel in a fast-paced, collaborative environment, we invite you to help shape the future of diagnostics with us.

HOW YOU WILL CONTRIBUTE

Develops and implements comprehensive regulatory, customer support, and quality strategies for the company's product(s). Directs the review and provides regulatory and quality guidance on related activities, ensuring adherence to government contracts and compliance with regulatory requirements for submissions. Plans and oversees activities in support of all regulatory submissions. Leads the development of international regulatory strategy, timelines, staffing and budgets. Works with leadership to incorporate implications of international regulatory strategy to compliance policies, regulatory filings, supply chain operations, marketing, sales, and external partners. Supports international sales through regulatory meetings and communication to stakeholders. Reviews final study reports, manufacturing process documentation, investigator brochures, study protocols, and other regulatory documentation as required. Interacts with key scientific and medical personnel within and outside the company to ensure timely and accurate regulatory compliance. Acts as primary liaison and coordinates meetings with Health Canada, FDA, EU and other health authorities as needed, representing the company with those agencies. As requested, communicates the company's position to internal and external stakeholders. Evaluation of external opportunities (e.g., new technologies) for regulatory implications. Manage Regulatory, Customer Support, and Quality teams in accordance with Company talent management practices. Actively review new regulatory requirements to maintain proficiency in worldwide regulations and communicate pertinent information. Act as a credible, reputable, and effective advocate for bioLytical.

WHAT YOU BRING

Minimum 10 years Quality and Regulatory Affairs experience with 5+ years leading and managing cross-functional teams. Minimum a bachelor's degree in a related field (preferably in a regulatory capacity) a master's degree or higher is an asset. Proven leadership and management skills to motivate and engage teams to work collaboratively and cross functionally to deliver exceptional results. Experience in ensuring Quality regulations are consistently followed. Direct organizational development of internal regulatory policies and internal practices. Deep knowledge and connection to all regulations (ISO13485, FDA, Health Canada, etc) and laws relevant to the industry. Experience working directly with production and research teams and maintain product development schedules through cross departmental interactions. Excellent interpersonal skills used to lead, resolve, and drive consensus among individuals from a variety of disciplines, levels, and cultures.

WHAT WE OFFER

Work on game-changing medical diagnostics that impact global healthcare. Lead robust quality management system with a highly skilled, mission-driven team. Collaborate with industry leaders, researchers, and regulatory bodies to shape the future of diagnostics. Enjoy a dynamic and fast-paced leadership role with direct influence on company strategy and innovation. A competitive total compensation package Extended health benefits including dental - 100% employer contribution 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 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:


$120,000-$140,000


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.