Vice President, Compliance

Are you a hands-on, visionary leader in regulatory affairs looking to make a global impact?

bioLytical is seeking an experienced and strategic Vice President, Compliance to lead and actively contribute to our global regulatory, clinical, 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 innovation 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 and clinical strategies for the company’s product(s).
- Directs the review and provides regulatory, clinical, and quality guidance on related activities, ensuring adherence to government contracts and compliance with regulatory and clinical requirements for submissions.
- Plans and oversees activities in support of all regulatory submissions.
- Identifying, selecting, and overseeing the qualification of clinical Contract Research Organizations and oversees the running of clinical studies.
- 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, clinical study protocols, clinical trial documentation and other clinical and 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 and clinical implications.
- Manage Regulatory, Quality and Clinical 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:
$125,000-$155,000

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

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