Director, Medical Events Group & NPR – Abbott Diabetes Care at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Diabetes CareIndustries

Requirements

Bachelor’s or Master’s in a scientific, medical, or technical discipline
Minimum 8–10 years of experience in Quality Systems, Regulatory Affairs, or Quality Assurance within the medical device industry
At least 5 years of leadership experience managing teams and complex regulatory processes
Expertise in global medical device reporting regulations (FDA, MHRA, Health Canada, EU MDR, etc.)
Strong verbal and written communication skills at all organizational levels
Proficiency in Microsoft Office Suite and familiarity with regulatory reporting systems
(Preferred) Prior experience in medical event reporting or post-market surveillance
(Preferred) Advanced knowledge of global vigilance requirements and risk management frameworks

Responsibilities

Define and implement global medical device reporting and vigilance strategies for Abbott Diabetes Care
Develop and enforce policies for capturing and documenting reportable events to comply with global requirements
Ensure adherence to CFR 803, 806, 820, ISO 13485, and other international standards
Oversee timely and accurate global filing of reportable events (FDA, Health Canada, MHRA, EU MDR, ROW)
Evaluate product safety issues, highlight risks to senior management, and drive mitigation actions
Provide leadership during regulatory audits and inspections (FDA, ISO, etc.)
Lead and develop the Medical Events Group team, fostering a culture of compliance and continuous improvement
Manage the No Product Return Investigation Team to ensure robust Device History Review (DHR) and documentation for non-returned product cases
Establish and maintain quality metrics to enhance process efficiency and data reporting
Represent Abbott in external regulatory discussions and standard-setting activities

Skills

Key technologies and capabilities for this role

FDA regulationsISO 13485EU MDRpost-market surveillancemedical device vigilanceregulatory reportingregulatory inspectionsauditsproduct investigations

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What are the key responsibilities or skills needed for this Director role?

The role requires expertise in defining global medical device reporting strategies, ensuring compliance with standards like FDA CFR 803, 806, 820, ISO 13485, and EU MDR, leading teams during regulatory audits, and managing product safety evaluations and investigations.

What is the company culture like at Abbott?

Abbott fosters a culture where you can do work that matters, grow and learn, care for yourself and family, be your true self, and live a full life; it is recognized as a great place to work, one of the most admired companies by Fortune, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this position?

A strong candidate will have strategic leadership experience in medical device vigilance, post-market surveillance, regulatory compliance with FDA, ISO 13485, EU MDR, and the ability to lead teams in medical event reporting and regulatory audits.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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