Associate Director Regulatory Affairs – Vascular (on-site)

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

This Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual will develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual will ensure that data is identified, obtained and effectively presented for the registration of products worldwide.

• Sets strategy and directs preparation of submissions for products to regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products.
• Provides guidance on regulatory requirements and strategies to product development project teams.
• Provides regulatory input for capital equipment and software, including knowledge of IEC standards (e.g., IEC 60601-1)
• Provides regulatory input on cybersecurity and Artificial Intelligence (AI)
• Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.
• Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals.
• Directs staff in implementing regulatory strategy and preparing regulatory submissions.
• Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Performs related functions and responsibilities, on occasion, as assigned.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communication.

• Bachelor’s Degree or an equivalent combination of education and work experience
• 5-7 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• 5-7 years’ experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Previous experience with 510k / PMA submissions
• Experience working with hardware/ software devices
• Familiarity with Predetermined Change Control Plans (PCCPs)
• Experience with Medical Devices

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