Principal RA Specialist

About the Role The Principal RA Specialist will be based on-site in Alameda, CA within Abbott's Diabetes Care Division. The role focuses on US submissions for new product introductions and regulatory strategy across the product lifecycle, including breakthrough diabetes management and digital health solutions. It requires leadership in premarket submissions for continuous glucose monitoring systems and interaction with regulatory agencies to drive timely approvals.

What You'll Do

• Develop global regulatory strategies for product development and lifecycle planning.
• Analyze regulatory outcomes vs initial concepts; recommend future strategies/actions.
• Provide technical leadership and strategic input on complex issues to business units.
• Anticipate regulatory obstacles and develop cross-functional solutions.
• Create project plans and timelines; lead data development for submissions.
• Write and edit technical documents; ensure compliance with regulations.
• Negotiate with regulatory authorities during development/review to obtain submission approval.
• Review and approve labeling to ensure compliance.
• Monitor emerging issues, negotiate with regulators, and identify solutions.
• Oversee licensing, registrations, listings, and patent information.
• Ensure post-marketing compliance; manage SOPs for product events.
• Contribute to crisis/issue management; analyze product problems and propose solutions.
• Oversee system for reporting product safety issues to regulatory agencies; provide input for recalls.
• Provide regulatory input for recall communications.

What We're Looking For

• Bachelor’s Degree in Chemistry, Life Sciences, Biology or equivalent.
• Experience in regulatory submissions for Combination Devices, IVDs, and/or Medical Devices.
• Experience with 21 CFR 820, ISO 13485, MDD and/or IVD Directive.
• Ability to operate in a highly matrixed, geographically diverse environment; able to work as part of a team and as an individual contributor in a fast-paced environment.

Nice to Have

• Regulatory Affairs Certification (RAC) is a plus.
• 5 years’ experience with Class II/III medical devices and/or biologics/drugs.
• Experience with 510(k) submissions, PMA supplements, US and EU/international medical device regulations.
• Familiar with Quality Systems standards, clinical investigations, ICH guidelines.
• Proficiency with MS Word, Excel, PowerPoint; experience in a broader enterprise/cross-division model.

Compensation & Benefits

• Health coverage: Employees can qualify for free medical coverage in the Health Investment Plan (HIP) PPO in the next calendar year.
• Retirement: Excellent retirement savings plan with high employer contribution.
• Education: Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
• Additional: Abbott is recognized as a great place to work with diverse benefits and opportunities across many countries.