Quality Assurance and Regulatory Affairs Director (Stealth Ophthalmology AI Venture)

 

Ascertain is a revolutionary, first in its class, partnership between Northwell Health, New York’s largest healthcare provider, and Aegis Ventures, an emerging venture creation studio backed by a leading global private investment firm. Ascertain creates and launches compelling next-generation AI-enabled health technology companies that advance healthcare outcomes at scale. By placing patient needs at the center of every business model, technology solution, and product we develop, our companies improve quality of care, patient experience, and longstanding health inequities – creating a virtuous cycle of positive healthcare and commercial impact.

 

 

One of Ascertain’s first ventures is focused on AI-enabled diagnostic solutions that use the eye as a window to healthcare. This venture has developed industry-leading AI-enabled software and hardware products that noninvasively diagnose eye and system health conditions. The venture is backed by one of the world’s most well-renowned experts in the development and application of AI systems in ophthalmology. The company has already secured regulatory approval and early commercialization in non-US markets.

 

As the venture is preparing for targeted US market entry and commercialization, we are seeking a highly capable, full-time, Quality Assurance and Regulatory Affairs Director to oversee the venture’s quality assurance and regulatory strategy. The Quality Assurance and Regulatory Affairs Director will own all work streams pertaining to the Quality Management System and regulatory communications/submissions to US and global regulatory authorities. This role will report directly to the Chief Executive Officer of the venture.

 

We anticipate that a successful candidate will be primarily experienced in quality assurance, while also possessing sufficient background in regulatory affairs to handle high-level strategy and enlist the assistance of outside consultants as needed. Specific activities include but are not limited to implementation and maintenance of a QMS for the global venture, as well as developing, implementing, and maintaining global regulatory strategies for the venture’s current and future products. The Quality Assurance and Regulatory Affairs Director will be a key part of the cross-functional interface between the venture’s management team and Aegis/Ascertain venture studio staff.

 

We envision the Quality Assurance and Regulatory Affairs Director to execute with a high degree of autonomy and ownership. We will also provide the mentorship and support required to succeed, and the opportunity to become a part of an early-stage company leadership team.

We are looking for a high-energy, operational leader with the technical, people, and organizational skills to manage complex responsibilities. The role will ideally be based in New York, although exceptional remote candidates will be considered.

 

Responsibilities

• Establish, manage, and maintain a Quality Management System for the global business, supporting multiple software as a medical device (SaMD) products
• Ensure compliance to Quality System Regulations, ISO 13485, IEC 62304, 21 CFR Part 820, FDA General Principals of Software Validation, Regulatory requirements, EU MDR etc
• Apply risk assessment principles in accordance with ISO 14971
• Prepare for and be responsible for success during regulatory authority audits and inspections
• Lead QMS and quality-related product improvements, including CAPAs, management review meetings, SOP and quality form updates
• Work closely with the venture’s leaders to plan a global regulatory submission strategy for the company’s product pipeline
• Own relationships with and collaborate closely with key external stakeholders, including quality and regulatory vendors/consultants
• Oversee preparation and submission of pre-submissions, 510(k) filings, de novo filings, and other communications to the FDA
• Oversee preparation and submission of MDR filings to achieve product clearance in Europe and other OUS geographies
• Manage and maintain FDA compliance, including product registration
• Manage and maintain compliance with MDR, including CE Mark applications via Technical Files

Candidate Profile

• Bachelor’s degree or equivalent in life sciences, healthcare, or a related field is required. Advanced degree in a similar field is a plus
• 6-8 years supporting medical device, digital health, or similar companies in quality assurance and/or regulatory affairs activities, with a strong track record of success
• Minimum of 4 years of managerial experience required
• Prior experience with SaMD/digital health products, especially related to ophthalmology or diagnostics strongly desired
• Additional professional certifications (e.g. RAC) strongly desired
• Deep understanding of ISO 13485 and demonstrated success implementing and managing QMS for software products
• Prior regulatory affairs leadership experience with 510(k), de novo, or PMA and/or CE marking.
• Experience in performing and responding to audits, inspections, and risk assessments
• Strong written and verbal communication skills, organizational and prioritization skill
• Must be able to work in a team environment
• Ability and willingness to travel as required