Associate Director Regulatory Affairs – Vascular (on-site)

The Opportunity

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. This role will have a strong focus on regulatory support for software-enabled medical devices and on-market/sustaining activities. The ideal candidate will bring experience leading regulatory strategy across the product lifecycle, and demonstrated experience in managing and developing regulatory professionals.

What You’ll Work On

• Set strategy and direct preparation of submissions for products to regulatory agencies, and interface with agencies in order to obtain timely approval to produce and market new products.
• Provide guidance on regulatory requirements and strategies to product development project teams.
• Provide regulatory leadership and strategic input for capital equipment and software-enabled medical devices, including applicable software and electrical safety standards (e.g., IEC 60601-1), and support regulatory considerations related to cybersecurity and Artificial Intelligence (AI).
• Lead regulatory strategy for on-market and sustaining activities, including product changes, regulatory impact assessments, maintenance of existing registrations/approvals, and other post-market regulatory activities throughout the product lifecycle.
• Maintain 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; communicate such knowledge to all internal stakeholders.
• Consult with and provide advice to senior management of the Company on strategies and plans for regulatory product approvals.
• Lead, develop, and direct regulatory staff in implementing regulatory strategy, supporting on-market products, and preparing regulatory submissions.
• Remain current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and train staff regarding changing regulations that affect regulatory submissions.
• Maintain knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
• Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence.
• Perform related functions and responsibilities, on occasion, as assigned.
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback.
• Maintain a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication.

Required Qualifications

• 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.

Preferred Qualifications

• 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
• Regulatory Affairs experience supporting software-enabled medical devices and/or products incorporating both hardware and software.
• Experience providing regulatory support for on-market/sustaining medical device products, including product changes and lifecycle management activities.
• Previous people management experience, including leading, developing, and coaching regulatory professionals, is highly preferred.
• Experience developing and executing regulatory strategies across the product lifecycle.
• Familiarity with Predetermined Change Control Plans (PCCPs)
• Experience with Medical Devices