Principle Regulatory Affairs Specialist - Diabetes Care (on-site)

JOB DESCRIPTION

The Principal RA Specialist will work on-site at Abbott’s Alameda, CA location in the Diabetes Care Division. This role focuses on US submissions for new product introductions, including breakthrough advancements in diabetes management and digital health technology solutions. Projects will focus on pre‑market submissions for continuous glucose monitoring systems. The individual will have department‑level influence, monitor and influence changing regulations, interface with regulatory agencies, develop innovative regulatory submission strategies, and provide executive management with regulatory metrics and information. Activities and Responsibilities Develop global regulatory strategies for product development and planning throughout the product lifecycle. Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Provide technical leadership and strategic input on complex issues to business units. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with regulatory and related teams. Work on sustaining activities. Create project plans and timelines. Lead functional groups in generating data to complete regulatory submissions. Write and edit technical documents. Administer regulatory requirements to achieve excellent compliance with no enforcement actions. Negotiate with regulatory authorities during development and review to ensure approval. Review and approve labeling for compliance. Monitor emerging issues and identify solutions. Negotiate internally and externally with regulatory agencies. Evaluate regulatory risks of corporate policies. Oversee processes for maintaining annual licenses, registrations, listings and patent information. Ensure compliance with post‑marketing approval requirements. Develop, implement and manage SOPs and systems to track product‑associated events. Contribute to crisis/issue management programs. Analyze product‑associated problems and propose solutions. Ensure safety issues and events are reported to regulatory agencies. Provide regulatory input for product recalls and communications. Required Qualifications Bachelor’s degree in a scientific discipline such as Chemistry, Life Sciences or Biology (or equivalent vocational qualifications). Experience in regulatory submissions for combination devices, in‑vitro diagnostic devices and/or medical devices. Experience with 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Preferred Qualifications 5 years’ experience with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. Experience with 510(k) applications, PMA supplements, US device regulations, or EU and other international device regulations and submissions. Familiarity with relevant regulatory requirements for medical devices, drugs and/or biologics including quality systems standards, clinical investigations and ICH guidelines. Experience with word processing, spreadsheet and presentation software. Experience working in a cross‑division enterprise model. Ability to work in a highly matrixed, geographically diverse environment. Ability to work independently and as a team in a fast‑paced, changing environment. Ability to leverage others to accomplish projects. Strong written and verbal communication skills at multiple organizational levels. Ability to multitask, prioritize and meet deadlines. Strong organizational and follow‑up skills with attention to detail. Ability to travel approximately 5%, including international travel. Compensation $100,000.00 – $200,000.00 (may vary by location). Location United States > Alameda: 2901 Harbor Bay Parkway Travel Yes, approximately 5 % of the time. EEO Statement Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link – English: EEO is the Law link – Spanish: #J-18808-Ljbffr Dormont Manufacturing Co