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

Abbott · Alameda, CA

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RegulatoryFull-time$100k–$200kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

Key requirements

Therapeutic area: Metabolic

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