Regulatory Associate

Location: Cambridge, Massachusetts

Position Type: Full-time

Company Mission: 

The Iterative Scopes mission is to empower doctors with real-time computer-aided detection and diagnostic tools powered by state-of-the-art computer vision and machine learning technology; improving patient outcomes by helping gastroenterologists detect and classify lesions in real-time, including those that often elude the human eye; and improving care worldwide by providing doctors across the globe with access to deep neural networks trained by the world’s best

and most experienced GI specialists.

 

Iterative Scopes is a venture backed company established by Jonathan Ng, MD a second time founder. The company has raised over $14M and is on track to be one of the fastest growing MIT startups. The scientific advisory board includes world-class gastroenterologists primarily based in Boston and leading MIT computer vision and machine learning researchers and faculty.

Job Overview:

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

 

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

 

This is a great opportunity for anyone interested in building up their regulatory skills and is looking for a hands-on experience with the ability to grow.

Skills & Requirements: 

  • Bachelor's Degree

  • 3+ years experience with medical device regulatory affairs

  • Strong written/verbal communication & interpersonal skills

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

Ideal Candidate Profile:

  • Experience with 510k and De Novo medical device submissions

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

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

  • Ability to engage with the FDA and outside FDA consultants to craft internal regulatory strategy 

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

Preferred Experience & Skills:

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

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

Additional Information: 

The Iterative Scopes advisory board includes leading MIT computer vision and machine learning researchers/faculty and world-class Boston-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. 

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