Regulatory Affairs and Quality Assurance

Future Fertility; Toronto; On-site; CAD 80,000 - 120,000; Full time

Job summary

An innovative company is seeking a Regulatory Affairs & Quality Assurance Lead to ensure compliance of AI-based software solutions with global standards. This role involves leading regulatory submissions, maintaining a robust quality management system, and collaborating with cross-functional teams to support market expansion. If you're passionate about the intersection of AI and healthcare and want to make a significant impact, this opportunity is for you! Join a mission-driven team that values respect and empowerment in a fast-growing environment where your contributions will shape the future of fertility care.

Qualifications

• 5+ years in regulatory affairs and quality assurance, preferably in software as a medical device.
• Deep knowledge of ISO standards and FDA regulations.

Responsibilities

• Lead regulatory strategy and submissions for software as a medical device in key markets.
• Maintain and improve the ISO 13485-certified Quality Management System.

Skills

Regulatory Affairs

Quality Assurance

Interpersonal Skills

Organizational Skills

Time Management

Education

Bachelor’s degree in business, engineering or similar technical/scientific field

Tools

ISO 13485

ISO 14971

IEC 62304

Job description

HYBRID

3 CHURCH STREET, TORONTO, ONTARIO, CANADA, M5E 1A9
FULL-TIME . MARCH 20, 2025

Description

At Future Fertility, we’re revolutionizing the IVF journey with AI-powered quality assessments that bring clarity and confidence to fertility care, starting with the egg. Our innovative technology is used by leading clinics worldwide, empowering both doctors and patients with data-driven insights to optimize treatment decisions for patients going through egg freezing or IVF.

As a fast-growing, mission-driven company, we’re looking for passionate, forward-thinking individuals to join our team. At Future Fertility, we are committed to building and fostering an environment where our employees feel heard, respected, and empowered. We take a “people-first” approach to our team, and we pride ourselves in being a values-driven organization.

If you’re excited about the intersection of AI, healthcare, and reproductive medicine—and want to make a real impact in people’s lives—we’d love to hear from you!

Let’s get started!

As the Regulatory Affairs & Quality Assurance Lead you will be responsible for ensuring that Future Fertility’s AI-based software solutions comply with global regulatory requirements and quality management standards. You will oversee regulatory submissions, maintain the quality management system (QMS), and collaborate with cross-functional teams to support the company’s expansion into new markets.

Responsibilities

• Lead regulatory strategy and submissions for software as a medical device (SaMD) in key markets, including Health Canada, FDA, CE, Latam, and APAC regions
• Monitor and interpret regulatory changes in AI/ML-based medical devices, ensuring company compliance with evolving guidelines.
• Prepare, submit, and maintain regulatory filings, including technical documentation, clinical evaluations, and post-market surveillance reports.
• Serve as the primary liaison with regulatory authorities and notified bodies.
• Work closely with product and engineering teams to ensure regulatory requirements are integrated into product development.

Quality Assurance

• Maintain and continuously improve Future Fertility’s ISO 13485-certified Quality Management System (QMS).
• Ensure compliance with Good Machine Learning Practices (GMLP) and regulatory guidelines for AI-driven medical devices.
• Lead internal and external audits, including notified body and customer audits.
• Develop and implement risk management processes in line with ISO 14971.
• Support post-market surveillance, complaints handling, and CAPA processes.

Qualifications

• 5+ years of experience in regulatory affairs and quality assurance, preferably with software as a medical device (SaMD) or AI-based technologies.
• Experience in the APAC region is an asset
• Bachelor’s degree program in business, engineering or similar technical/scientific field is required
• Deep knowledge of ISO 13485, ISO 14971, IEC 62304, MDR, FDA regulations, and Health Canada’s SaMD framework.
• Experience with regulatory submissions for AI/ML-based medical devices is a strong asset.
• Proven track record of leading audits and regulatory approvals.
• Excellent Team player with strong interpersonal skills; ability to effectively work with colleagues on all levels and functions in a fast-paced, short-timeline, detail-oriented environment.
• Excellent organizational and time management skills