Associate Director Regulatory Affairs – Vascular (on-site)

About the role

Abbott is a global healthcare leader that creates breakthrough science to improve people’s health. The Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division.

Responsibilities

• 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.
• Solves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• 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.

Requirements

• 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

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
• Familiarity with Predetermined Change Control Plans (PCCPs)
• Experience with Medical Devices

Benefits

Abbott offers a comprehensive benefits package including:

• 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.

Pay

The base pay for this position is $129,300.00 – $258,700.00. In specific locations, the pay range may vary from the range posted.