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Senior Regulatory Affairs Manager – Apac - Diabetes Care (On-Site)

9+ years
$128,000 – $256,000
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Regulatory Affairs Manager – APAC (On-site) – Alameda, CA

Job Summary

Abbott’s Diabetes Care Division is hiring a Senior Regulatory Affairs Manager – APAC to join its on-site team in Alameda, California. This leadership role will oversee a regulatory team focused on the APAC region, driving product registration strategies, compliance frameworks, and global submissions for life-changing diabetes care technologies. If you have 9+ years in regulatory affairs and expertise in medical devices or in vitro diagnostics (IVD), this is a career-defining opportunity to lead innovation and shape regulatory processes in high-growth international markets.


Key Responsibilities

  • Lead and coach regulatory staff managing submissions for the APAC region.

  • Develop and execute regulatory strategies and timelines for product registrations.

  • Act as regulatory SME across cross-functional project teams.

  • Review and compile regulatory submissions for IVDs and medical devices in APAC markets.

  • Ensure product labels, marketing materials, and packaging meet APAC regulatory standards.

  • Oversee post-marketing regulatory compliance, licenses, and listings.

  • Provide strategic guidance on authority queries and policy development.

  • Evaluate design and manufacturing changes for global regulatory impact.

  • Support internal and external audits and regulatory inspections.

  • Monitor emerging regulatory issues and propose proactive solutions.


Required Skills & Qualifications

  • Bachelor’s degree in life sciences, engineering, or related field (Master’s preferred).

  • Minimum 9 years of relevant regulatory affairs experience.

  • Experience managing regulatory teams or large-scale international projects.

  • Strong understanding of APAC regional regulations and submission processes.

  • Knowledge of ISO, EN standards, and country-specific regulatory guidelines.

  • Proven success in product lifecycle management, global strategy, and post-market surveillance.

  • Excellent verbal and written communication skills across organizational levels.

  • RAC certification is a plus.


Perks & Benefits

  • Base salary: $128,000 – $256,000

  • Free medical coverage via Health Investment Plan (HIP)

  • High-contribution employer retirement savings plan

  • Tuition reimbursement and student loan assistance via Freedom 2 Save program

  • Free undergraduate education via the FreeU benefit

  • Global career mobility and leadership development

  • Inclusive work culture recognized worldwide for diversity, women in leadership, and innovation


Company Overview

Abbott is a world-renowned healthcare company with more than 114,000 employees in over 160 countries. In the Diabetes Care Division, Abbott leads the way with revolutionary glucose monitoring technologies. As a top employer in the medical device industry, Abbott empowers professionals to create products that change lives and improve health outcomes globally.


Work Mode

On-site – Alameda, California, United States


Call to Action

Shape the future of diabetes care and elevate your regulatory affairs career with a global leader. Take your expertise to the next level by joining Abbott’s high-impact APAC regulatory team.
Apply now to lead change and make a global impact.

Apply on Abbott Careers