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

Abbott seeks a Principal Regulatory Affairs Specialist to lead regulatory strategy for diabetes care products in its Alameda, California office. The role involves managing US premarket submissions for continuous glucose monitoring systems, developing lifecycle regulatory strategies, and serving as a technical expert on complex submissions and on-market changes. The position offers influence at the department level with opportunities to engage regulatory agencies and shape innovative submission approaches.

Responsibilities

• Develop global regulatory strategies for product development across the product lifecycle
• Lead premarket submissions for continuous glucose monitoring systems portfolio
• Provide technical leadership on complex regulatory issues to business units
• Anticipate regulatory obstacles and develop solutions with cross-functional teams
• Negotiate with regulatory authorities and manage post-marketing compliance requirements

Requirements

• Bachelor's degree in chemistry, life sciences, biology, or equivalent vocational qualification
• Experience with regulatory submissions for combination devices, in vitro diagnostics, or medical devices
• Knowledge of 21 CFR 820, ISO 13485, Medical Devices Directive, and IVD Directive requirements
• Five years' experience with Class II or Class III medical devices, biologics, or drugs
• Familiarity with 510(k) applications, PMA supplements, and US device regulations
• Regulatory Affairs Certification (RAC) preferred
• Experience with quality systems, clinical investigations, and ICH guidelines