Associate Director Regulatory Affairs – Vascular (on-site)

Abbott • Westford, MA

18d • $129,300 - $258,700 • Onsite

About The Position

The Associate Director, Regulatory Affairs will work on-site at Abbott’s Westford, Massachusetts location in the Vascular Division. The role combines scientific, regulatory, and business knowledge to ensure products meet applicable legislation and requirements. The individual will influence department-level work, serve as an expert resource internally and externally, and develop and supervise regulatory professionals. The role includes interaction with regulatory agencies and trade associations, advising executive management, and ensuring data is identified and effectively presented to support worldwide product registration. Its focus includes regulatory support for software-enabled medical devices and on-market and sustaining activities, with regulatory strategy across the product lifecycle and management and development of regulatory professionals.

Abbott Vascular develops minimally invasive, cost-effective products for vascular disease, including stents, guide wires, balloon dilatation catheters, imaging catheters and software, and vessel closure devices.

The position is part of Abbott’s Regulatory Operations job family and Vascular Division. It is based at 4 Robbins Road, Westford, Massachusetts, and requires approximately 10% travel. The work shift is listed as standard.

Requirements

• Bachelor’s degree or an equivalent combination of education and work experience.
• 5–7 years of experience in a regulated industry, such as medical products or nutritionals.
• 5–7 years of regulatory experience preferred; experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may be considered. Higher education may compensate for years of experience.
• Ability to lead, develop, and direct regulatory staff.
• Ability to work on-site in Westford, Massachusetts and travel approximately 10% of the time.

Nice To Haves

• Bachelor’s degree in science, mathematics, engineering, or a medical field.
• Master’s degree in a technical area or an MBA.
• Ph.D. in a technical area or a law degree.
• Regulatory Affairs certification, such as RAC from the Regulatory Affairs Professionals Society.
• Previous experience with 510(k) or PMA submissions.
• Regulatory Affairs experience supporting software-enabled medical devices or products incorporating both hardware and software.
• Experience providing regulatory support for on-market or sustaining medical-device products, including product changes and lifecycle management.
• People-management experience, including leading, developing, and coaching regulatory professionals.
• Experience developing and executing regulatory strategies across the product lifecycle.
• Familiarity with Predetermined Change Control Plans (PCCPs).
• Medical-device experience.

Responsibilities

• Set regulatory strategy and direct preparation of product submissions; interface with regulatory agencies to obtain timely approvals to produce and market new products.
• Advise product development project teams on regulatory requirements and strategies.
• Provide regulatory leadership and strategic input for capital equipment and software-enabled medical devices, including applicable software and electrical safety standards, cybersecurity, and artificial intelligence considerations.
• Lead regulatory strategy for on-market and sustaining activities, including product changes, regulatory impact assessments, maintenance of registrations and approvals, and other post-market regulatory activities throughout the product lifecycle.
• Maintain expert knowledge of laws, regulations, and enforcement decisions affecting Quality Assurance, manufacturing, and Research and Development, and communicate relevant information to internal stakeholders.
• Advise senior management on strategies and plans for regulatory product approvals.
• Lead, develop, and direct regulatory staff in implementing strategy, supporting on-market products, and preparing submissions.
• Stay current on regulatory developments, requirements, and industry trends; train staff on changes affecting submissions.
• Resolve or facilitate resolution of problems, identify their causes, and help prevent recurrence.
• Perform related functions and responsibilities as assigned.
• Hire and retain a diverse, highly qualified staff; provide ongoing performance feedback and maintain a safe, professional work environment.
• Support company initiatives and requirements related to Quality Management Systems, Environmental Management Systems, and other regulatory matters.
• Comply with FDA and international regulations, other regulatory requirements, company policies, procedures, processes, and task assignments, while maintaining positive and cooperative communication.

Benefits

• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

• Job Type: Full-time
• Career Level: Director