Quality Assurance and Regulatory Affairs

Job Title: Director – Quality Assurance and Regulatory Affairs
Location: Remote to start due to COVID-19; HealthMyne offices, Madison, WI;
Reports to: Chief Executive Officer
Directly Supervises: Quality Assurance Team

 

Core Duties and Responsibilities
HealthMyne is seeking a highly qualified individual to lead the Regulatory Affairs and Quality Assurance team. The primary duties for this position include administration of the quality management system, evaluating and improving the quality processes, participating as regulatory lead on product releases, keeping up to date with industry standards for medical devices, leading the Quality Assurance Team.

  • 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

 

Qualifications
Minimum Required Skills:

  • Bachelor’s Degree required; Master’s Degree in Regulatory Affairs preferred.
  • 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 preferred.

Knowledge and Skills:

  • 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.

Additional requirements:

  • Candidates must be authorized to work in the U.S.

Physical Demands

  • Office, desk, and computer-based work

Benefits

  • 100% Paid Health Plan
  • 401K (currently no company match)
  • Stock in early stage, high growth company
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