Haemonetics

About the Company

Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite, and hospital transfusion services. To learn more about Haemonetics, visit www.haemonetics.com.

Listed Jobs

Company Name

Haemonetics

Job Title

Vice President, Global Quality Assurance and Regulatory Affairs

Job Description

**Job Title** Vice President, Global Quality Assurance & Regulatory Affairs **Role Summary** Senior executive leading the global QA/RA organization, shaping quality & regulatory strategy, ensuring compliance with FDA, ISO, AABB and other standards across the product lifecycle, and driving continuous improvement and innovation. **Expectations** - 25 % global travel. - Board‑level presentations on quality & compliance. - Management of QA/RA budget and long‑term plans. - Act as Management Representative for the quality management system. - Deliver strategic leadership and stakeholder influence across R&D, Operations, Marketing and Commercial teams. **Key Responsibilities** - Lead and oversee the global QA/RA organization, ensuring regulatory compliance worldwide. - Serve as primary liaison with FDA and other regulatory bodies; manage all compliance interactions. - Develop, implement and continuously improve quality assurance programs, policies and processes. - Define and execute global regulatory strategies for new product submissions, pre‑market notifications and lifecycle management. - Provide senior leadership with regulatory and compliance advice; lead corrective actions and continuous improvement initiatives. - Direct worldwide QA/RA staff: organizational design, talent development and performance management. - Monitor trends, complaints, deviations; report findings and improvement opportunities to senior leadership. - Represent QA/RA in strategic business decisions, including clinical study design and regulatory approvals. - Prepare and manage short‑ and long‑term QA/RA plans and budgets. - Ensure quality management system processes are established, implemented and maintained. - Promote quality and customer‑requirements awareness across the organization. - Maintain ethical standards and compliance with all applicable laws and company policies. **Required Skills** - Exceptional written and verbal communication. - Strong stakeholder management and influencing capabilities. - Proven leadership and team‑building skills. - Ability to manage complexity and lead diverse global teams. - Critical thinking and strategic partnership skills. **Required Education & Certifications** - Bachelor’s degree in a scientific, business, healthcare or technical discipline (required). - Master’s degree preferred. - Minimum 10 years of direct QA/RA management experience in medical device design and production. - Minimum 10 years operating in FDA‑regulated cGMP manufacturing environments, with successful FDA interactions and product submissions. - Proven experience managing global QA/RA teams and functions. - Experience in quality systems management for medical devices. - Regulatory Affairs Certification (RAC) or equivalent preferred.

Boston, United states

On site

Senior

17-12-2025