Director, Regulatory

At **bioLytical**, we don’t just develop rapid diagnostics—we redefine access to healthcare by ensuring answers are available when and where people need them most. Our success depends on more than breakthrough science and product innovation: it requires **visionaries**who can navigate the complex global landscape and clear the path to market.

We’re looking for a **Director, Regulatory Affairs**to lead regulatory strategy. This is your opportunity to **own the global regulatory roadmap**for our portfolio, anticipate and interpret change, and work hand-in-hand with executive leadership to deliver life-saving technologies to patients worldwide.

This role goes beyond traditional regulatory submission management. You’re **shaping regulatory strategy as a business driver**. Externally, you’ll lead the charge guiding teams through the intricacies of international approvals, own relationships with global health authorities, and ensure bioLytical continues to lead with speed, compliance, and credibility. Internally, you’ll be at the intersection of product development and global approvals —guiding our diagnostics from concept to clinic, from Canada to the world.

**WHAT YOU’LL OWN**

**Regulatory Strategy & Leadership**

- Define and own bioLytical’s global regulatory strategy, aligning submissions and approvals with corporate growth objectives.

- Serve as the regulatory voice on leadership teams, providing foresight, guidance, and influence on product design, development, and commercialization.

- Lead and mentor the regulatory team, fostering a culture of ownership, agility, and strategic thinking.

- Anticipate regulatory shifts, evaluate impact, and position bioLytical to respond with speed and confidence.

**Global Market Access**

- Direct and lead the preparation and defense of high-impact submissions across global markets, including:

- FDA 510(k)s, PMAs, Supplements

- CE Marking dossiers and change notifications

- WHO Prequalification and international authority filings

- Oversee global licensing and registration activities to ensure uninterrupted market access.

- Maintain strong, proactive relationships with regulators worldwide to advocate for bioLytical’s products and shape favorable outcomes.

**Compliance & Post-Market Oversight**

- Lead the oversight of product labeling, promotional materials, and claims to ensure global compliance.

- Own the post-market regulatory framework, including complaint handling, device reporting, and surveillance, ensuring regulatory obligations are met with integrity and rigor.

- Provide regulatory guidance on clinical evaluations and studies—supporting design, review, and approval where regulatory insight is essential.

**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.

- **10+ years of hands-on experience**in regulatory affairs in medical devices or diagnostics with 5+ years leading and managing teams.

- In-depth 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 influence decision-making at both executive and regulatory authority levels.

- Skilled at leading complex submissions across multiple jurisdictions, balancing detail with strategic vision.

- 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 experience with WHO PQ or other emerging market pathways.

**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:
$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 i