Regulatory Affairs Leader, Global Strategy

Abbott; Alameda (CA); On-site; USD 149,000 - 297,000; Full time

Benefits offered by this job

HIP PPO medical plan

Retirement plan

Tuition reimbursement

FreeU education benefit

Career development

Recognized by Fortune

Job summary

Abbott in Alameda, CA is seeking an Associate Director, Regulatory Affairs to lead regulatory strategies across the product lifecycle in Diabetes Care. This role focuses on guiding submissions, influencing agencies, and aligning with global requirements for innovative diabetes management solutions.

You will mentor regulatory professionals, develop SOPs, and collaborate across teams to ensure compliant, timely product approvals in a dynamic, mission-driven environment.

Qualifications

• Bachelor's degree required in a relevant field.
• 5-7 years of experience in a regulated industry (e.g., medical products).
• Experience in regulatory preferred; other related areas considered.

Responsibilities

• Develop global regulatory strategies for product development and lifecycle.
• Lead complex regulatory submissions and negotiations with authorities.
• Provide strategic input to cross-functional teams and management.
• Recruit, develop, and manage regulatory professionals.
• Ensure compliance and maintain annual licenses and registrations.

Skills

Regulatory affairs knowledge

Leadership

Strategic thinking

Communication

Education

Bachelor's degree

M.S./MBA preferred

Ph.D. helpful

RAC certification helpful

Job description

Abbott in Alameda, CA is seeking an Associate Director, Regulatory Affairs to lead regulatory strategies across the product lifecycle in Diabetes Care. This role focuses on guiding submissions, influencing agencies, and aligning with global requirements for innovative diabetes management solutions.

You will mentor regulatory professionals, develop SOPs, and collaborate across teams to ensure compliant, timely product approvals in a dynamic, mission-driven environment.