Associate Director Regulatory Affairs - Vascular (on-site)

JOB DESCRIPTION Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans the spectrum of healthcare, including diagnostics, medical devices, nutritionals, and branded generic medicines. The Opportunity The Associate Director, Regulatory Affairs will work on‑site at our Westford, MA location in the Vascular Division. In this role you will combine scientific, regulatory, and business knowledge to enable products that are developed, manufactured, or distributed to meet required legislation. You will develop and supervise regulatory professionals and serve as a recognized expert resource both within Abbott and externally. What You’ll Work On Set strategy and direct preparation of submissions for products to regulatory agencies, and interface with agencies to obtain timely approval. Provide guidance on regulatory requirements and strategies to product development project teams. Provide regulatory input for capital equipment and software, including IEC standards (e.g., IEC 60601‑1). Provide regulatory input on cybersecurity and Artificial Intelligence. Maintain expert knowledge of laws, regulations, and enforcement decisions related to QA, manufacturing, and R&D issues that may impact company operations. Consult with senior management on strategies and plans for regulatory product approvals. Direct staff in implementing regulatory strategy and preparing regulatory submissions. Maintain current knowledge of regulatory requirements and industry trends, and train staff on changes. Resolve and facilitate resolution of problems, including identifying causes to prevent reoccurrence. Hire and retain a diverse, highly qualified staff and provide performance feedback. Maintain a safe and professional work environment and support company initiatives for QMS, EMS, and other regulatory requirements. Required Qualifications Bachelor’s Degree or an equivalent combination of education and work experience. 5‑7 years of experience in a regulated industry (e.g., medical products, nutritionals). 5‑7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, or operations. Previous experience with 510(k) / PMA submissions. Experience working with hardware/software devices. Familiarity with Predetermined Change Control Plans (PCCPs). Experience with Medical Devices. Preferred Qualifications Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. M.S. in a technical area or M.B.A. preferred. Ph.D. in a technical area or law helpful. Certification is a plus (e.g., RAC from the Regulatory Affairs Professionals Society). Additional Information Job Family: Regulatory Operations Division: AVD Vascular Location: United States > Massachusetts > Westford Work Shift: Standard Travel: Yes, 10 % of the Time Medical Surveillance: No Significant Work Activities: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) The base pay for this position is $129,300.00 – $258,700.00. In specific locations, the pay range may vary. Abbott is an Equal Opportunity Employer, committed to employee diversity. We welcome and encourage a diverse workforce. For more information on equal‑employment opportunities, the following documents are available (links omitted in this description). EEO is the Law – English and EEO is the Law – Spanish. #J-18808-Ljbffr Abbott Laboratories