Regulatory Affairs Manager
Hyperfine Research is on a mission to democratize healthcare by making MRI technology accessible to everyone around the world. We are reinventing medical imaging and championing a new era of healthcare by building the first ever bedside MRI system. Our breakthrough technology enables portable point-of-care MRI and significantly lowers the cost, power, and weight versus that of traditional fixed MRI systems.
Hyperfine is a well-funded, rapidly growing health-tech incubator founded by award-winning scientist and highly successful serial entrepreneur, Dr. Jonathan Rothberg. Hyperfine benefits from being a 4Catalyzer company, an incubator of health-tech companies (most notably Butterfly Network) who has raised over $700 million in funding. The Hyperfine device was 510k FDA cleared in February 2020.
Joining Hyperfine Research is the opportunity to redesign the future of healthcare through the power of technology. Embark on a journey with us to maximize global impact, motivated by the idea that our products will change the lives of millions along with the people you love.
Regulatory Affairs Manager ensures internal and external compliance with stated practices and procedures and supports regulatory and agency inspections and/or audits as necessary. Maintains and disseminates knowledge of latest, worldwide regulatory standards and guidance.
As part of our team, your core responsibilities will be:
- Provide input and comment to regulations and standards which may affect the company’s products and services. Provide training on regulatory requirements and issues to company personnel to assure compliance.
- Determine global regulatory strategies for market introduction of new and modified device platforms. Ensure proper communication of regulatory strategies to responsible functions, including Product Development, Sales and Marketing, Service, Manufacturing.
- Prepare US and non-US product submissions (510(k), Technical Files, Licenses, and International registrations).
- Ensure proper facility registration and device listings are maintained with the appropriate regulatory agencies.
- Develop/provide regulatory reports and inputs into management review, as required.
- Maintain knowledge and application skills of regulations and standards.
- Minimum 8-10 years in a Regulatory Affairs (RA) and/or Quality Assurance (QA) role within the medical device industry
- Bachelor of Science or higher degree in a technical discipline
- Detail oriented, hands-on, proactive problem solver
- Direct involvement with pre-submission (Q-sub) meeting with FDA
- Direct involvement with multiple FDA 510(k) clearances for class II or III devices
- Track record of navigating swiftly and efficiently through the regulatory process as part of a team ensuring project and company success
- Extensive experience interpreting FDA guidelines
- Extensive experience understanding approval approaches
- Extensive experience working directly with FDA
- CE marking for class IIa, IIb, or III devices
Ideally, you also have these skills/experiences/attributes (but it’s ok if you don’t!):
- Experience in hosting audits (ISO, MDR/MDD, FDA, MDSAP)
- Knowledge of multiple types of US and international regulatory filing procedures
- Knowledge of 21CFR820, ISO13485, ISO14971, EU MDR/MDD, IEC60601
- Experience in submissions for medical imaging devices
- Experience with magnetic resonance devices
- Experience with artificial intelligence/deep learning regulatory submission
You Deeply Identify with Core Hyperfine Research Values:
- Efficient & Speedy - you get work done in a fraction of the time as industry peers
- Intellectually Curious - you are thoughtful & inquisitive; people enjoy working with you because they learn from you
- Mission-Driven & Committed - you are passionate about the company's purpose and are immensely productive
- Team Oriented - you celebrate and take joy in the success of others on the team
We offer great perks:
- Fully covered medical insurance plan, and dental & vision coverage - as a health-tech company, we place great worth on our teams’ well-being
- Competitive salaried compensation - we value our employees and show it
- Equity - we want every employee to be a stakeholder
- Pre-tax commuter benefits - we make your commute more reasonable
- Free onsite meals + kitchen stocked with snacks
- 401k plan - we facilitate your retirement goals
- Beautiful office near the ocean-front in historic Guilford, Connecticut
- The opportunity to build a revolutionary healthcare product and save millions of lives!
Hyperfine Research is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.