Analyst II, Post Market Surveillance

Abbott; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Abbott is a global healthcare leader with a broad portfolio spanning diagnostics, medical devices, nutritionals and branded medicines. The Postmarket Surveillance Analyst will manage complaint handling, investigations, and regulatory reporting while collaborating with cross-functional teams to ensure patient safety and regulatory compliance.

The role involves reviewing complaint data, preparing technical evaluations, and maintaining documentation in accordance with FDA regulations and company

Qualifications

• Review complaint communications for regulatory compliance and patient safety impact.
• Independently perform investigations with customers or field staff.
• Prepare customer letters with investigation findings.
• Participate in cross-functional complaint review groups and archive records.
• Train new employees to the complaint handling process and support QA/Legal.

Responsibilities

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Communicates with field representatives and internal teams regarding information needed for product complaints, maintaining positive communications.
• Independently performs investigations with customers or field staff.
• Assess if a medical device report needs to be filed with global regulatory agencies and file within required timeframes.
• Prepare customer letters with investigation findings.
• Participate in cross-functional complaint review groups and archive records.
• Support the Quality Management Systems, EMS, and regulatory requirements.
• Train new employees and provide support to Legal regarding product complaints.

Skills

Regulatory compliance

Investigations

Cross-functional collaboration

Data entry

Medical devices knowledge

Job description

JOB DESCRIPTION:

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 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Under the direction of management, the Postmarket Surveillance Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering). The other role of the Postmarket Surveillance Analyst is performing evaluations on various types of returned complaint products (e.g. disposable and implantable products, electronic and electro-mechanical medical devices and systems) such as performing non-destructive and destructive testing; reviewing of Device History Records; coordinating product testing/analysis with other SJM departments and external consultants; preparing technical reports of evaluation findings; operating and maintaining the Postmarket Surveillance Laboratory equipment.

What You'll Work On

• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations. Initiates and manages the complaint file. Maintains accurate entry of complaints in the database.
• Communicates verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices). Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned.
• Independently performs investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management.
• Prepares customer letters with investigation findings. Is diligent of any unusual trends in product complaints and communicates them to management.
• Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, new product teams, risk management meetings). Archives complaint records and retrieves information on closed investigations.
• Ensures accurate department procedures and work instructions are maintained. Train new employees to the complaint handling process. Provide support to the Legal Department regarding product complaints.
• Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Postmarket Surveillance Analyst (product evaluations):Performs product evaluations in a timely manner. Executes product evaluations to develop a well-documented and accurate root cause evaluation. Coordinates product evaluations with other SJM departments and external consultants. Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance. Reviews