Associate Director Regulatory Affairs – Vascular (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. As an Associate Director, Regulatory Affairs, you will work on-site at our Westford, MA location in the Vascular Division, combining knowledge of scientific, regulatory, and business issues to enable products to meet required legislation. You will develop and supervise regulatory professionals, provide guidance on regulatory requirements and strategies to product development project teams, and interface with outside regulatory agencies and trade associations.

Requirements

• Bachelor’s Degree or an equivalent combination of education and work experience
• 5-7 years’ experience in a regulated industry
• Regulatory experience preferred
• Previous experience with 510k / PMA submissions
• Experience working with hardware/ software devices
• Familiarity with Predetermined Change Control Plans (PCCPs)
• Experience with Medical Devices
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Benefits

• Career development with an international company
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• The Freedom 2 Save student debt program
• FreeU education benefit