Associate Director Regulatory Affairs – Vascular (on-site)

Abbott - Westford, MA

Hiring: Associate Director Regulatory Affairs – Vascular (on-site) Company: Abbott Location: Westford, MA Job Posted Time: 2026-09-11 18:06:26 Employment Type: On-site Target Skills & Keywords : AI, R About the job Required Skills: •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. •What You’ll Work On •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 a Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!