Manager Regulatory Compliance
Location: Westford, MA, USA
Category: Quality
Work Mode: On-site
Compensation Range: $97,300.00 – $194,700.00 per annum
Job Summary:
Abbott Vascular, a leader in innovative and minimally invasive medical device solutions, is hiring a Manager of Regulatory Compliance at its Westford, MA facility. This role is responsible for developing, maintaining, and enhancing global quality systems to ensure adherence to FDA QSR, ISO 13485, and international regulatory standards, supporting a broad portfolio of intravascular imaging products.
Key Responsibilities:
Develop, establish, and maintain comprehensive quality systems, policies, procedures, and training materials.
Provide expert guidance in the implementation and improvement of global quality systems in compliance with US 21 CFR 820 (QSR) and ISO 13485 standards.
Identify and drive opportunities for risk reduction, cost efficiency, and quality system improvements across global sites.
Lead divisional projects and cross-functional initiatives to improve quality system performance.
Oversee the assessment and fulfillment of quality system resource needs.
Define and monitor effective Quality Metrics; address performance gaps proactively.
Recruit, mentor, and manage a high-performing quality systems team.
Ensure the work environment remains safe, compliant, and professional.
Required Skills & Qualifications:
Bachelor’s Degree in Science, Engineering, or a related discipline.
Minimum 10 years of quality functional experience, including 3 years in direct leadership roles.
Proven leadership skills with at least 5 years of experience in setting goals, coaching teams, and improving quality outcomes.
Minimum 5 years of project management experience (preferred).
Expertise in FDA QSR, ISO 13485, and international medical device regulations.
Strong problem-solving, communication, and cross-functional leadership skills.
Perks & Benefits:
Competitive base salary: $97,300.00 – $194,700.00 annually.
Free medical coverage for employees.
Exceptional retirement savings plan with employer contribution.
Tuition reimbursement & student debt assistance.
Career growth opportunities within a globally recognized healthcare leader.
Work with one of Fortune’s Most Admired Companies.
Company Description:
Abbott Vascular specializes in life-changing medical device technologies designed to improve vascular health. With a presence in over 160 countries, Abbott offers a dynamic work culture focused on innovation, quality, and patient outcomes.
Work Mode:
On-site (Westford, Massachusetts, USA)
Call to Action:
Ready to advance your career in regulatory compliance with a global healthcare leader? Apply now to join Abbott Vascular’s Quality Assurance team and drive impactful quality improvements worldwide.
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