Vice President, Global Quality Assurance and Regulatory Affairs

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.

We are seeking a dynamic and experienced Vice President of Global Quality Assurance and Regulatory Affairs to lead our global QA/RA organization. This executive 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. This is a critical leadership role that partners closely with R&D, Operations, Marketing, and Commercial teams to enable innovation while maintaining the highest standards of quality and compliance. The role is based in our Boston Global HQ at 125 Summer Street and requires approx. 25% travel to our global locations.

Key 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.

Qualifications :

Education:

• Bachelor's degree in a scientific, business, healthcare, or technical discipline (required). Master's degree (preferred).

Experience:

• 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

Skills:

• 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.

EEO Policy Statement

Pay Transparency:

The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role.

In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly 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, and/or health and welfare benefits.

Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email AskHR@Haemonetics.com.

The base salary range for this role is: