Post Market Surveillance Manager

1 week ago

Oakland, California, United States Abbott Laboratories Full time
About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Career Development and Benefits

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity

The Post Market Surveillance Manager provides direct supervision and management to staff responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest of world for the division's products. Is proficient with medical event reporting and complaint handling policies and procedures. Manages staff to evaluate potentially reportable complaints in compliance with applicable regulations. Ensures that reportable events are filed with worldwide regulatory agencies in compliance with regulations. Ensures that ADC complaints are reviewed within established timeframes. Elevates complaints requiring ADC Management and Medical Affairs guidance, participates in discussions and decision making process to determine reportability. Ensures compliance is maintained and that employees are trained and following the required site level policies and procedures. Anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross functional areas to recommend actions to resolve the issues.

Responsibilities

Responsible for scheduling day-to-day activities of medical events group staff to ensure timely review of medical event files. Ensures potentially reportable complaints are assessed against criteria for reportability and reports are filed as necessary in compliance with regulations. Works closely with Customer Service, Complaint Handling, and Complaint Investigation teams to ensure that the appropriate information is obtained from complainants to make sure an accurate and timely assessment of reportability is made. Establishes processes and procedures for medical event reporting within the framework of the complaint handling system. Utilizes good judgment and makes timely decisions considering the facts and data at hand; champions specific projects; knows when to escalate to management. Actively recruits, interviews and participates in the hiring process of Medical Events Group members. Participates as a team member and team leader to monitor the productivity of the group, set priorities, and shift resources as appropriate to meet department goals. Sets standards and monitors staff performance; establishes the motivational climate and productivity goals for the group; provides performance feedback; writes and conducts appraisals for employees. Assists in development of development and training plans. Coordinates changing priorities and organizes process improvement projects. Uses tools effectively to monitor progress and results.

Requirements

Bachelor's Degree (± 16 years) or an equivalent combination of education and work experience. Knowledge and experience of Quality Systems Regulations (21CFR820), as well as, Medical Device Reporting (21CFR803) and ISO standard 13485. Requires experience with complaint handling (21CFR820.198). Minimum 5 years In the medical device field. Minimum 3 years Management, supervisory or team leadership experience required.

Estimated Salary

$109,300.00 – $218,500.00 per year.

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