Associate Director – Medical Events Group (On-site)
Location: Alameda, California
Company: Abbott Diabetes Care Division
Work Mode: On-site
Employment Type: Full-Time
Salary Range: $146,700 – $293,300 (may vary by location)
Job Summary
Abbott, a global leader in healthcare and medical devices, is seeking an Associate Director to lead the Medical Events Group in its Diabetes Care Division located in Alameda, California. In this strategic and compliance-focused role, you will oversee the global medical device reporting process, ensuring safety, quality, and compliance with international regulations including FDA MDR, Health Canada, EU Vigilance, and ISO 13485 standards. This leadership opportunity is ideal for seasoned professionals in post-market surveillance, regulatory affairs, or medical safety reporting.
Key Responsibilities
Lead the Medical Events Group (MEG) and manage global vigilance reporting for all diabetes care products.
Ensure compliance with FDA (CFR 803, 806, 820), Health Canada, EU/EFTA, and other international medical event reporting requirements.
Represent Abbott during audits and inspections by regulatory authorities (e.g., FDA, ISO).
Implement and maintain regulatory reporting policies and procedures across global markets.
Oversee timely reporting and filing decisions of reportable medical events.
Liaise with medical, legal, quality, and risk teams to ensure regulatory readiness.
Provide post-market surveillance insights to inform product safety and efficacy decisions.
Monitor and improve medical event reporting metrics for Quality Management Reviews.
Participate in regulatory strategy development and contribute to industry guidance feedback.
Train and manage team members, driving compliance and operational excellence.
Required Skills & Qualifications
Bachelor’s, Master’s, or Ph.D. in a relevant field (e.g., life sciences, medical technology, pharmacy).
Minimum 5 years of experience in Quality Systems, Regulatory Affairs, or Post-Market Surveillance.
At least 3 years in a functional management or leadership role.
Strong working knowledge of medical device regulations, especially in the U.S., EU, and Canada.
Previous experience with medical event reporting systems is highly preferred.
Proficiency in Microsoft Office, strong communication, organizational, and multitasking skills.
Perks & Benefits
Competitive salary: $146,700 – $293,300
Free employee medical coverage through HIP PPO Plan
Generous employer contributions to a retirement savings plan
Tuition reimbursement and FreeU education program
Freedom 2 Save student loan assistance
Global career development opportunities
Recognized as a Top Employer for diversity, women, and scientists
Company Description
Abbott is a globally recognized healthcare innovator dedicated to helping people live healthier lives through advanced medical devices, diagnostics, branded generics, and nutritionals. The Diabetes Care Division is transforming glucose monitoring with industry-leading sensing technologies and data-driven solutions that empower patients worldwide.
Work Mode
On-site – Alameda, California
Call to Action
Ready to lead global post-market surveillance and drive medical safety at one of the world’s most admired healthcare companies? Apply now to join Abbott’s Diabetes Care Division and be part of innovation that transforms lives.
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