About the Role
Our Regulatory Affairs team is seeking a strong leader to help build and grow the team in support of advancing our mission to deliver AI-driven products and services that fundamentally improve patient outcomes in gastrointestinal disease. This is an important leadership position that will help to guide the company through a critical stage of growth and through submission of its first product to the FDA for review.
The Sr. Director/VP of Regulatory Affairs will be part of the clinical and scientific team, reporting to the SVP of Scientific and Regulatory Affairs, and will play a key role in both strategic development and tactical execution to regulatory submissions. The successful candidate will guide the company’s regulatory work for SKOUT, a novel artificial intelligence (AI)-aided polyp detection device, as well as other AI products in development for Crohn’s disease and ulcerative colitis.
Development of regulatory strategy, both with US and international regulatory bodies such as the FDA, EMA, and others
Oversight of all regulatory submissions for Iterative Scopes, as well as overall management of regulatory activities and team
Coordination of internal and external capabilities in developing regulatory documents and narrative
Strategic input to scientific strategy to ensure data generation for regulatory requirements
Monitoring of external environment to keep up to date of regulatory initiatives and trends
Serve as a member of senior scientific leadership team and as internal SME of regulatory activity and needs for entire organization
Development of a regulatory team and overall regulatory capabilities for Iterative Scopes (over time)
Leadership of all planning, preparation, and engagement with regulatory agencies (such as the FDA)
Coordinating and leading all corporate meetings and discussions with regulatory agencies
Performing ongoing retrospective reviews of regulatory submissions for quality improvement, key learnings, and process optimization
Ideal Candidate Profile:
Compliance and or regulatory background
Strategic and innovative thinker
Ability to understand corporate strategic goals and contribute to execution of regulatory activities to support those goals
Ability to communicate ideas and influence without authority
Team mentality and ability to work in matrixed environment
Willing to roll up sleeves and dive in where needed
Experience in the healthcare environment
Previous management experience, especially in high-growth start-up environment
Previous experience in building and developing teams
Experience in regulatory submissions
Advanced degree required
7+ years of experience in regulatory activities, including working with the US FDA (preferably in the pharmaceutical industry)
2+ years of experience managing a team with direct reports
Ability to juggle multiple submissions and discussions
Capability to prioritize most important work
Ability to work across multiple groups to pull together strong submission documentation
Ability to coordinate between internal and external parties
Strong communication skills (both verbal and written)
Agency mindset and advanced knowledge of industry compliance, rules and regulations
Ability to represent Iterative Scopes to external parties
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About the Company
Iterative Scopes is an early-growth stage startup on a mission to revolutionize the treatment of gastrointestinal diseases with computer vision. We are backed by leading venture firms, top pharmaceutical companies as well as category defining healthcare leaders including; Obvious Ventures, Eli Lilly, Janssen Pharmaceuticals, Founders of Flatiron Health, Livongo, Path.AI, PAIGE, WHOOP!, Okta, and Recursion Pharmaceuticals.
Iterative Scopes is a venture backed company established by Jonathan Ng, MD a second time founder. The scientific advisory board includes world-class gastroenterologists and leading MIT computer vision and machine learning researchers and faculty.
The Iterative Scopes advisory board includes leading MIT computer vision and machine learning researchers/faculty and world-class Boston-area physicians and gastroenterology experts.oston-area physicians and gastroenterology experts.
Recruitment & Staffing:
Agencies - Iterative Scopes does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Iterative Scopes or its employees is strictly prohibited unless contacted directly by Iterative Scopes' internal operations team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Iterative Scopes, and Iterative Scopes will not owe any referral or other fees with respect thereto.