Safe Health Systems is looking for an experienced Vice President of Quality Assurance and Regulatory Affairs to represent RA and QA on cross-functional project teams. This person will be responsible for implementing the overall regulatory strategy, quality assurance program, quality management system (QMS), and ensuring compliance with regulations and guidelines for medical devices, and affiliated software products.
You will develop and drive a work culture committed to compliance, quality, and customer focus.
As a fast-paced startup, we are looking for people who love to learn, can wear multiple hats and are detail-oriented. We expect people to work independently in their domain while also collaborating effectively with cross-functional teams. Successful execution will lead to significant career growth opportunities.
Essential Functions and Accountabilities:
Quality Assurance Key Responsibilities:
- Fully implement QMS that is compliant with ISO 13485 and FDA 21 CFR part 820.
FDA premarket submissions: EUA, 510K, DeNovo, etc. as needed
- Ensure company efforts (Design Control, Risk Management) comply with regulations and external standards.
- As management representative, coordinate ISO and customer audits, and FDA inspections.
- Direct Document Control functions and ensure all change orders are reviewed for QMS impact.
- Participate in document development as needed.
- Manage analysis and records for customer complaints, NCMR, RMA, deviations, and CAPA.
- Manage receiving inspections and outgoing quality functions.
- Manage verification and validation of software system requirements, traceability, and testability.
- Manage the company’s risk management process to ensure the appropriate risk assessment is performed and documented.
- Monitor and report Key Performance Indicators (KPI’s) related to company quality objectives and lead Quality System management Review (QSMR) meetings.
Regulatory Affairs Key Responsibilities:
- In consultation with external counsel, set US and international regulatory strategy for multiple Safe Health Systems products.
- Manage regulatory submissions and maintenance activities.
- Serve as Safe Health Systems regulatory representative in activities with Health Authorities.
- Provide regulatory support relating to labeling, promotional material, product changes and documentation.
- Ensure compliance with regulations and laws and manage requirements resulting from new regulations.
- Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure all QMS processes in the company are compliant with current requirements.
Knowledge, Skills and Abilities:
- Strong knowledge of Quality Management Systems (QMS); particularly ISO13485, ISO 14971, 21 CFR 820, IEC 62304, and MDSAP.
- Demonstrated knowledge of regulations and procedures required for development of new software-based medical devices and associated software mobile applications.
- Understanding of HIPAA compliance and software data security measures, a plus.
- Experience developing and writing SOPs.
- Experience with regulatory submissions for 510(k), EUA and CE Mark; other OUS submissions a plus.
- Familiarity with the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence, a plus.
Experience: Minimum of 8 years experience in regulatory and quality in the diagnostic medical device industry.
Education: B.S./B.A. in a science or related life science field; advanced degree preferred