Senior Director, Regulatory Affairs - Diabetes Care

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

Benefits offered by this job

Free medical coverage in HIP PPO plan

Excellent retirement savings plan

Tuition reimbursement / FreeU program

Employee education benefits

Job summary

Abbott is seeking an Associate Director Regulatory Affairs to lead global regulatory strategy for diabetes care products from our Alameda, CA location. You will shape submission strategies, mentor teams, and partner with cross-functional groups to navigate FDA and EU regulations while safeguarding patient access and product quality.

This role requires 5-7 years in regulated industries and a bachelor's degree, with advanced certifications preferred.

Qualifications

• Bachelor's degree required; advanced degrees preferred.
• 5–7 years in a regulated industry; regulatory or closely related experience.
• Strong written, verbal, and organizational skills; ability to lead teams.

Responsibilities

• Develop global regulatory strategies across product lifecycle.
• Lead preparation of regulatory submissions and documentation.
• Mentor regulatory professionals and coordinate cross-functional teams.
• Navigate FDA and international regulations to protect patient access.

Skills

Communication skills

Cross-functional teamwork

Prioritization

Regulatory leadership

Education

Bachelor's degree

Master's degree preferred (technical or MBA)

PhD helpful (technical or law)

Tools

FDA QSR experience

EU MDR experience

SaMD familiarity

Job description

Abbott is seeking an Associate Director Regulatory Affairs to lead global regulatory strategy for diabetes care products from our Alameda, CA location. You will shape submission strategies, mentor teams, and partner with cross-functional groups to navigate FDA and EU regulations while safeguarding patient access and product quality.

This role requires 5-7 years in regulated industries and a bachelor's degree, with advanced certifications preferred.