Director of Quality and Regulatory Affairs
- Guilford, CT, USA
At 4Catalyzer we are transforming 21st century medicine by solving today’s most challenging problems in the biomedical sciences. We aspire to create significant societal impact and are motivated by the idea that our products will change the lives of people we love. We seek the talent of truly gifted, self-starting and driven individuals to help advance this mission. We provide a stimulating environment, surrounded by brilliant, highly committed individuals who are given both the autonomy and project ownership to solve difficult problems and be the first to publish.
Hyperfine Research (4Catalyzer Company) is a well-funded, rapidly growing "stealth" 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.
Quality and Regulatory Affairs Lead coordinates all activities involving development, implementation and maintenance of quality management systems and compliance across the company. This position is ultimately 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 inspections and/or audits as necessary.
· Minimum 7 years in a QA leadership role within the medical device industry with knowledge in GMP and GCP experience
· Bachelor of Science or higher degree in a technical discipline
· Experience in medical imaging strongly preferred
· Demonstrated experience in QA oversight and management of products through the lifecycle of medical device product development;
· Experienced QA leadership background with a track record of establishing and maintaining quality systems, practices and policies in device development environment;
· Deep experience with establishing and maintaining ISO, CFR, GxP, and other relevant compliant quality management systems across the device spectrum;
· 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;
· Lead, support, and participate in auditing activities and regulatory inspections; evaluate responses to audit findings for adequacy and assurance of risk management
· Track record of successfully working with and managing third-party vendors;
· Knowledge of 510(k), PMA, international regulatory filings, and ongoing submission maintenance requirements a plus;
4Catalyzer is an equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability, or Veteran status.