RetiSpec is a Toronto-based medical AI company that aims to enable widespread early and accurate detection of neurodegenerative disease markers through a simple eye exam. RetiSpec's AI solutions leverage existing retinal imaging cameras available in most eye clinics to provide real-time results at the point of care — this means that the experience is familiar and comfortable. RetiSpec's AI solutions are currently available for Research Use Only.

RetiSpec is seeking a HEAD OF REGULATORY AND CLINICAL AFFAIRS to lead our regulatory activities and clinical development program. The successful candidate will play a pivotal role in driving the transition of our AI solutions from research use to clinical adoption, by ensuring compliance with regulatory requirements and overseeing the successful execution of clinical studies. With 7+ years of experience in regulatory affairs and clinical development, the Head of Regulatory and Clinical Affairs will provide strategic leadership and expertise to support RetiSpec's mission of transforming neurodegenerative disease detection.

With new disease-modifying drugs coming to market, the Alzheimer’s landscape is at an important inflection point; making this an exciting and impactful time to be working in this space. This role will have the opportunity to drive positive change to patient health outcomes.

Responsibilities and Accountabilities:

• Develop and execute the regulatory and clinical development strategy for RetiSpec's AI-driven products, in alignment with company objectives and regulatory requirements to obtain and maintain regulatory approvals in key markets
• Oversee the planning, design, and execution of clinical research studies to support regulatory submissions and commercialization efforts, ensuring adherence to study protocols and ethical standards
• Lead the preparation and submission of regulatory documents (e.g., IDE, ITA, 510(k), De Novo, MDL, EU MDR) to regulatory agencies worldwide, ensuring compliance with applicable regulations and guidelines
• Lead interactions with regulatory authorities on behalf of RetiSpec (e.g., FDA, Health Canada, EMA), including responding to inquiries, managing regulatory submissions, and facilitating interactions to support product registrations, submissions, and clearances or approvals
• Collaborate cross-functionally with internal teams, external partners, and clinical investigators to drive regulatory and clinical activities and achieve company goals
• Ensure compliance with relevant regulations, standards, and guidelines (e.g., ISO 13485:2016 and MDSAP, 21 CFR part 820 and 801, SOR/98-282), throughout the product lifecycle
• Provide strategic guidance and support for product development initiatives, ensuring alignment with regulatory requirements and standards
• Stay abreast of emerging regulatory trends, changes in legislation, and industry best practices to proactively identify potential risks and opportunities
• Develop and maintain relationships with key opinion leaders, clinical investigators, CROs, and regulatory consultants to support regulatory and clinical development activities
• Provide leadership, mentorship, and guidance to regulatory and clinical team members, fostering a culture of excellence, innovation, and collaboration

Knowledge and Experience:

• Bachelor's degree in life sciences, engineering, or related field; advanced degree (e.g., MSc, PhD, MD) preferred
• 7+ years of progressive experience in regulatory affairs and clinical development within the medical device or pharmaceutical industry, with a track record of successful regulatory submissions and clinical studies
• Experience with medical devices, particularly Software as a Medical Device (SaMD); asset if you have experience in diagnostics, with a focus on ophthalmology/optometry or neurology
• Extensive knowledge of global regulatory requirements, including FDA regulations (e.g., 510(k), De Novo PMA), EU MDR, and other relevant standards
• In-depth knowledge of clinical trial design, execution, and regulatory requirements for medical devices, including experience with IDE, ITA, 510(k), and EU MDR submissions
• Proven experience in planning, managing, and executing clinical studies and trials, from Phase I through post-market surveillance
• Demonstrated track record of successfully obtaining regulatory clearances/approvals for medical devices or diagnostic products in major markets (e.g., US, EU)
• Excellent communication, presentation, and interpersonal skills, with the ability to effectively interface with internal stakeholders, external partners, and regulatory authorities
• Strategic mindset with the ability to anticipate challenges, identify opportunities, and develop innovative solutions to drive business objectives
• Strong leadership and management skills, with the ability to inspire and motivate cross-functional teams and drive results in a fast-paced startup environment
• Experience managing direct reports and building high-performing teams

Our ideal RetiSpec team member should also be:

• Highly proficient at critical and analytical thinking
• Vigilant and scrupulous - exceptional attention to detail and best practices
• A great communicator - interact effectively in a team environment
• A fast learner and ready to join a fast-growing AI start-up in the medical field
• Able to prioritize activities and handle multiple projects in ambiguous or quickly changing environments
• A great problem-solver - you will be challenged!
• Self-motivated, organized, and capable of working independently and in a collaborative or team environment
• Happy to join us in-person in the Toronto office with some hybrid work structure options

RetiSpec is committed to fostering an inclusive, barrier-free, and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require any accommodations during the application or interview process, please let us know and we will work with you to meet your needs.