Vice President, Global Quality Assurance and Regulatory Affairs

Haemonetics is seeking a Vice President of Global Quality Assurance and Regulatory Affairs to lead our global QA/RA organization. This role will be responsible for shaping and executing the company’s quality and regulatory strategy, ensuring compliance with global standards, and driving continuous improvement across the product lifecycle.

Requirements

• Lead and oversee the global QA and RA organization, ensuring compliance with FDA, ISO, AABB, and other regulatory requirements across all geographies.
• Serve as a liaison with regulatory bodies, including the FDA, and manage all compliance-related interactions.
• Develop and implement robust quality assurance programs, policies, and processes to ensure product performance and customer satisfaction.
• Drive global regulatory strategies for new product submissions, pre-market notifications, and lifecycle management.
• Provide leadership and vision for quality objectives aligned with Haemonetics’ business goals.
• Advise senior leadership on compliance issues and readiness for inspections; lead corrective actions and continuous improvement initiatives.
• Direct worldwide QA/RA staff, including organizational design, talent development, and performance management.
• Monitor trends, complaints, and deviations to identify opportunities for improvement and report findings to leadership.
• Represent QA/RA in strategic business decisions, including clinical study design and regulatory approvals.
• Prepare and manage short- and long-term plans and budgets for the QA/RA function.
• Occasionally present updates to the Board of Directors on quality and compliance matters.

Benefits

• 401(k) with up to a 6% employer match and no vesting period
• Employee stock purchase plan
• Flexible time off
• Accrual of three to five weeks’ vacation annually (based on tenure)
• Accrual of up to 64 hours (annually) of paid sick time
• Paid and/or floating holidays
• Parental leave
• Short- and long-term disability insurance
• Tuition reimbursement
• Health and welfare benefits