Regulatory Affairs Manager

Job Location

14 Arrow St, Cambridge, MA 02138, USA

Job Type

Full Time

Category

Regulatory

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About the Role

Job Description:

We are growing our team and looking to add an enthusiastic and organized Regulatory Affairs Manager with medical device experience working with US and EU regulations. The core responsibilities of this role will be drafting regulatory submissions for various geographies (primarily US and EU) for software medical device products, as well as managing the Quality Management System activities of the company. This is a dynamic role that requires leadership, attention to detail, and the ability to learn and adapt quickly in a fast-paced company environment.


The Regulatory Affairs Manager will work closely with leaders across Iterative Scopes to help define and execute on regulatory strategy.


This is a great opportunity for an experienced individual interested in strengthening their regulatory skills and is looking for a unique opportunity on a growing team.

Requirements

Ideal Candidate Profile:

  • Interest in managing the entire medical device submission process from start to finish

  • Ability to engage with the FDA (CDER & CBER), and outside advisors to craft and formulate regulatory strategy for the company

  • Excellent interpersonal skill, able to clearly and consistently communicate with senior leaders of the company

Minimum Qualifications:

  • Bachelor’s Degree

  • 5 years or more experience with medical device regulatory affairs

  • Strong written / verbal communication and interpersonal skills

  • Interest in working in a fast-paced start-up environment

  • Experience with 510k, De Novo, or PMA medical device submissions

  • Track record of leading/managing multiple concurrent projects (with different deadlines) in a highly cross-functional environment

Preferred Qualifications:

  • Experience with software as a medical device, AI/ML a major plus

  • Familiarity with the FDA Quality System Regulation (QSR) and/or ISO 13485

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About the Company

Company Mission:

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.

Additional Info: 

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.