About this role
About the Role The Associate Director Regulatory Affairs will shape and execute regulatory strategies across Abbott's Diabetes Care product lifecycle from development to post-market, leading high-performing teams and interfacing with regulatory agencies to enable patient access and compliance. This role is based on-site in Alameda, CA.
What You'll Do
- Develop global regulatory strategies for product development and planning throughout the product lifecycle.
- Analyze regulatory outcomes and recommend future strategies; provide technical leadership on complex issues.
- Anticipate obstacles and develop solutions with regulatory and related teams; create project plans and timelines.
- Lead and develop regulatory professionals; recruit and manage talent; evaluate performance.
- Negotiate with regulatory authorities, review labeling for compliance, and ensure post-marketing requirements are met.
- Identify needs for new regulatory policies and SOPs; oversee licenses, registrations, listings, and patent information.
- Oversee product safety reporting systems, crisis/issue management, and regulatory input for recalls.
- Collaborate cross-functionally to ensure timely regulatory submissions and strategic insights for executive management.
What We're Looking For
- Bachelor's degree; 5-7 years in a regulated industry (preferably regulatory; others considered).
- Experience in regulatory submissions, cross-functional teams, and ability to manage multiple priorities.
- Strong writing and communication skills; strategic and analytical thinker.
Nice to Have
- Bachelor's in computer science, math, engineering, or medical fields; MS in technical area or MBA; PhD helpful; RAC certification.
- Experience with Class III US/EU submissions and SaMD; FDA QSR and EU MDR; direct regulatory authority interfacing.
- 7-10 years in regulated industry; regulatory domain preferred; software/systems R&D background acceptable.
Compensation & Benefits
- Health coverage in HIP PPO; excellent retirement savings with high employer contribution; tuition reimbursement and FreeU education benefit; Freedom to Save debt program.
- Recognized as a great place to work in dozens of countries and for diversity, working mothers, female executives, and scientists.
- Opportunity to shape regulatory strategy in a mission-driven organization with visibility and leadership.