Associate Director, Regulatory Affairs

Responsibilities

• Develop and execute global regulatory strategies for product development throughout the entire product lifecycle
• Provide technical leadership and strategic input on complex regulatory issues to various business units
• Lead functional groups in the development of data required for regulatory submissions
• Recruit, develop, and manage a high-performing team of regulatory professionals
• Negotiate with regulatory authorities during the development and review process to ensure submission approval
• Monitor emerging regulatory issues and identify solutions to mitigate risks
• Oversee compliance with product post-marketing approval requirements and manage product-associated events

Requirements

• Bachelor's degree
• 5-7 years of experience in a regulated industry (e.g., medical products)
• Experience in regulatory affairs, quality assurance, R&D, or scientific affairs

Preferred Qualifications

• Experience with Class III US and EU submissions and Software as a Medical Device (SaMD)
• Knowledge of FDA QSR and EU MDR regulations
• Experience interfacing directly with regulatory authorities
• Advanced degree (M.S., M.B.A., Ph.D., or Law) in a technical or relevant field
• Professional certification such as RAC from the Regulatory Affairs Professionals Society
• Strong ability to work effectively on cross-functional teams and manage competing priorities

Benefits

• Career development opportunities within an international company
• Health Investment Plan (HIP) PPO medical coverage
• Retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits

About the Company

Abbott is a global healthcare leader that creates breakthrough science to improve people’s health. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in more than 160 countries.