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.
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