Associate Director, Medical Events Group (On-site, Alameda, CA)
Job Summary
Abbott’s Diabetes Care Division in Alameda, CA, is hiring an Associate Director for the Medical Events Group. This senior role oversees global medical device vigilance, post-market surveillance, and regulatory reporting for Abbott’s diabetes products. The position ensures worldwide compliance with FDA, ISO 13485, and other global regulatory standards, while providing leadership to the Medical Events Group and acting as a key representative during regulatory inspections and audits.
Key Responsibilities
Serve as the primary liaison for regulatory, risk management, and legal concerns.
Define and implement global medical device reporting and vigilance strategies.
Develop and enforce policies for capturing and documenting reportable events to comply with global requirements.
Ensure division adherence to CFR 803, 806, 820, and ISO 13485 standards.
Lead the Medical Events Group (MEG) in executing worldwide post-market surveillance activities.
Oversee timely, accurate global filing of reportable events in accordance with regulations.
Interpret evolving regulatory requirements and develop compliant processes and systems.
Evaluate product safety issues, highlight risks to management, and drive mitigation actions.
Provide leadership during regulatory audits and inspections (FDA, ISO, etc.).
Establish and maintain Quality Metrics to enhance process efficiency and data reporting.
Represent the division in external regulatory discussions and standard-setting activities.
Required Skills & Qualifications
Bachelor's, Master's, or PhD in a related scientific, medical, or technical discipline.
Minimum 5 years of experience in Quality Systems, Regulatory Affairs, or Quality Assurance within the medical device industry.
At least 3 years of management or supervisory experience.
Expertise in global medical device reporting regulations (FDA, Health Canada, EU MDR, etc.).
Strong verbal and written communication abilities at all organizational levels.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Excellent organizational skills with the ability to manage multiple priorities and projects.
Preferred Qualifications
Prior experience in Medical Event reporting or post-market surveillance.
Demonstrated problem-solving, critical thinking, and decision-making skills.
Ability to lead cross-functional teams and engage stakeholders across functions.
Perks & Benefits
Salary Range: $146,700 – $293,300 annually.
Free medical coverage via Abbott’s HIP PPO medical plan.
Exceptional retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student loan program, and FreeU bachelor’s degree benefit.
Career development opportunities within a Fortune-recognized global healthcare leader.
Company Description
Abbott is a global leader in healthcare innovation, offering advanced solutions in diagnostics, medical devices, nutrition, and pharmaceuticals. Abbott’s medical devices improve the lives of over half a million people with diabetes and other chronic conditions worldwide.
Work Mode
On-site – Alameda, California, United States
Call to Action
Ready to drive global medical device vigilance and safety excellence? Apply now to join Abbott’s leadership team and shape the future of diabetes care worldwide.
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