Quality Assurance and Regulatory Affairs Manager
- Guilford, CT, USA
Hyperfine Research (4Catalyzer Company) is a well-funded, rapidly growing medical technology company founded by Jonathan Rothberg, PhD in 2014. Our companies (like: Butterfly Network) build medical devices that have never been built before - bridging together cutting-edge electrical, mechanical and software engineering with artificial intelligence, thereby bringing down device costs, reducing device size, increasing usability and creating breakthrough products. We have a world-class team of engineers, whose focus is to build these innovative devices, save the lives of the ones we love and democratize medicine around the world.
Today, 90% of the world population does not have access to MRI. Hyperfine is on a mission to bring MR technology to every patient anywhere, anytime, regardless of income or resources.
Quality Assurance and Regulatory Affairs Manager coordinates all activities involving development, implementation and maintenance of quality management systems and compliance across the company. This position is responsible for establishing and maintaining the quality management system and ensuring quality standards are upheld across the organization, as well as establishing and maintaining key processes, procedures and documentation to support regulatory requirements and filings. Ensures internal and external compliance with stated practices and procedures and support regulatory and agency ispections and/or audits as necessary.
- Minimum 4 years in a QA/RA leadership role within the medical device industry
- GMP and GCP experience
- Bachelor of Science or higher degree in a technical discipline
- Experience in medical imaging strongly preferred
- Hands-on proactive problem solver
- Excellent documentation and dashboarding skills
- Detail-oriented with compulsive disposition
- Experience with Software Quality Assurance/SDLC strongly preferred
- Demonstrated experience in QA oversight and management of products through their lifecycle of medical device product development;
- Experienced QA leadership background with a track record of establishing and maintaining quality systems, practices and policies in the device development environment;
- Deep experience with establishing and maintaining ISO, CFR, GxP, and other relevant compliant quality management systems;
- Experience applying GxP Quality knowledge through standard operating procedures (SOPs) to facilitate business operations and when needed develop procedural solutions to resolve quality and compliance challenges.
- Experience applying Quality Systems (e.g., change control, deviations, CAPA, complaint management, and documentation management among others)
- Thorough knowledge of FDA assessments of QSR processes
- Track record of successfully working with and managing third-party vendors
- Lead, support, and participate in auditing activities and regulatory inspections; evaluate responses to audit findings for adequacy and assurance of risk management
- In-person knowledge of 510(k), De Novo, PMA, and international CE, C-FDA regulatory filing procedures
- Knowledge of MDSAP, EU MDR
We provide visa assistance for non-U.S. applicants
Our competitive compensation plan includes salary, stock options and outstanding benefits.
4Catalyzer, Inc. is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability, or Veteran status.
4Catalyzer, Inc. does not accept agency resumes.