Our client, Abbott, is a global healthcare leader that helps people live more fully at all stages of life. Their portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional’s, and branded generic medicines. Their 103,000 colleagues serve people in more than 160 countries.
This position works out of Temecula, California location in AVD Vascular business unit. Their solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. The products are also utilized by laboratory management to ensure efficiency in their operations.
Our client provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Job Summary:
Our client is seeking a meticulous and detail-oriented Product Surveillance Analyst to oversee the initiation, management, and assessment of product complaints within our organization. The ideal candidate will independently manage complaint files, ensure accurate entry of complaints into the database, and communicate effectively with field representatives regarding necessary information specific to product complaints.
Main Responsibilities:
- Initiate and manage complaint files, ensuring accuracy and completeness of information.
- Enter and maintain complaints in the database, ensuring data integrity and timely updates.
- Communicate effectively with field representatives regarding information needed for specific product complaints, engaging with stakeholders such as physicians, hospital personnel, sales representatives, and international offices.
- Independently assess complaints to determine the necessity of filing medical device reports with various global regulatory agencies (e.g., FDA, ECA) and submit reports within required timeframes.
- Diligently monitor and identify unusual trends in product complaints, promptly communicating findings to management.
- Ensure compliance with US FDA regulations, other regulatory requirements, company policies, operating procedures, and assigned tasks.
- Maintain positive and cooperative communications and collaboration with employees, customers, contractors, and stakeholders at all levels.
Qualifications:
- Four-year degree, preferably in the healthcare or science fields, or 2-year degree and relevant experience supporting complaint handling investigations.
- Relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work duties.
- Proficient understanding of regulatory guidelines and compliance requirements related to complaint handling in the healthcare or medical device industry.
- Strong attention to detail and accuracy in maintaining complaint files and database entries.
- Excellent communication skills, both written and verbal, with the ability to collaborate effectively across various teams and stakeholders.
- Ability to independently assess and determine appropriate actions based on complaint assessments.
The Analyst in this role may perform two distinct functions within complaint handling:
- Complaint Investigation Management: Involves receiving and investigating reports of worldwide complaints/events on various products, entering information into the complaint database, independently determining and filing appropriate medical device reports with regulatory agencies, participating in cross-functional teams, and providing information on product complaints to relevant teams (e.g., Regulatory, Quality Engineering).
- Perform other related duties and responsibilities as assigned by management.
This job description will be reviewed periodically and is subject to change by management.