Haemonetics · 8 hours ago
Vice President, Global Quality Assurance and Regulatory Affairs
Boston, MA
Full-time
Onsite
Director/Executive
$251K/yr - $340K/yr
10+ years expHaemonetics is a dynamic company seeking a Vice President of Global Quality Assurance and Regulatory Affairs to lead their QA/RA organization. This role involves developing and executing quality and regulatory strategies, ensuring compliance with global standards, and driving continuous improvement across the product lifecycle.
BiotechnologyConsultingHealth CareMedicalMedical Device
Responsibilities
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
Acts as Management Representative having authority that includes:
Ensures that processes needed for the quality management system are established, implemented, and maintained
Reports to leadership on the performance of the quality management system and any need for improvement
Ensures the promotion of awareness of quality and customer requirements throughout the organization
Ensures that all organizational activities and operations are implemented in accordance with the highest ethical standards and are carried out in compliance with company policies and local, state, federal, and international regulations and laws
Qualification
Required
Bachelor's degree in a scientific, business, healthcare, or technical discipline
Min. 10 years of direct management experience in QA/RA for the design and production of medical products
Min. 10 years of experience operating within FDA-regulated cGMP manufacturing environments, including successful FDA interactions and product submissions
Experience managing global teams
Proven success in managing regulatory affairs functions
Experience in quality systems management for medical devices
Exceptional verbal and written communication skills
Strong stakeholder management and influencing capabilities
Effective leadership and team-building skills
Ability to manage complexity and lead diverse global teams
Critical thinking and strategic partnership skills
Preferred
Master's degree
Benefits
401(k) with up to a 6% employer match and no vesting period
An employee stock purchase plan
Flexible time off for salaried employees
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
Company
Haemonetics
Haemonetics is a provider of blood and plasma supplies and services.
1001-5000 employees
H1B Sponsorship
Haemonetics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (3)
2022 (2)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.75B2024-05-21Post Ipo Debt· $600M
2021-03-01Post Ipo Equity· $435M
2019-05-23Post Ipo Equity· $10M
Leadership Team
Christopher Simon
President and Chief Executive Officer
Christopher Lindop
CFO and VP Business Development
Recent News
2025-12-02
2025-11-21
2025-11-19
Company data provided by crunchbase