Position: Director of Quality Assurance and Regulatory
Location: Madison, WI
Start Date: January 1, 2022
Our client is in search of a Director of Regulatory and Quality Affairs to join their senior leadership team. With it's flagship Therapy Response Module, the company offers clinicians with real-time evidence-based imaging insights that aid in decision-making for patient care and reduce delivery costs.
- Ensure the quality system is kept up to date with industry standards.
- Discuss the status of current projects and possible changes to the regulations, quality system or product with the senior leadership team.
- Act as the Management Representative with governing bodies and assessment bodies, including quality and medical device audits
- Coordinate obtaining and maintaining clearance of the medical device(s).
- Keep up-to-date on regulations, standards, and other areas that affect the compliance of the quality system or product.
- Manage on-going RA tasks such as, but not limited to, Complaint Handling, Change Control, Risk Assessment, Post-Market Surveillance, Corrective and Preventive Actions
- Lead Quality Assurance Team responsible for Verification & Validation plans and execution of related activities as part of Product Realization
- 5+ years previous experience in regulatory and/or quality assurance within the healthcare software medical device industries.
- 3-5 years experience in a management role, with experience growing, supporting, and mentoring a highly skilled team.
- Experience in regulatory interactions and submissions is preferred.
- Extensive knowledge of quality management industry standards.
- Exceptional attention to detail and time-management skills.
- Familiarity with current FDA 21 CFR parts 11 & 820, ISO 13485, ISO 14971, IEC 62304, Medical Device Directive (EU MDD), Medical Device Regulation (EU MDR)
- Able to communicate well with others and give thorough directions.
- Ability to effectively collaborate and communicate throughout multiple levels of an organization.
- Understanding of medical devices, scientific and clinical terminology, and the software development process
What's In It For You?:
The opportunity to work at one of the fastest growing Top 10 technology startups in Madison, WI. This is a 100% remote, contract opportunity where you have the chance to use your skills to help launch a new product in groundbreaking medical and scientific trials.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.