Apply on Employer Site

Abbott · 1 day ago

Analyst I Postmarket Surveillance

Plano, TX

Full-time

Onsite

New Grad, Entry Level

$51K/yr - $101K/yr

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Analyst I Postmarket Surveillance will be responsible for managing product complaints, conducting investigations, and ensuring compliance with regulatory requirements for medical devices.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Communicates verbally and in writing both internally and externally to SJM regarding information needed specific to new product complaints (e.g. physicians, hospital personnel, sales representatives, international offices), initiates and manages the complaint file

Investigates complaints/events in a timely manner. Maintains accurate entry of complaints in database. 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. Prepares customer letters with findings. Records condition of returned products including observations, photographs. Coordinates product testing/analysis with other departments and external consultants

Prepares technical reports of analysis/findings--Tracks returned products within the database, as appropriate; Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings; Interprets technical product specifications, Device History Records, or measurements obtained; and Utilizes safe bio-hazard and chemical handling practices at all times

Duties associated with either role : Is diligent of any unusual trends in product complaints; Participates in cross-functional complaint review groups on a regular basis or as requested (e.g. cross-functional complaint teams, rapid customer response team, Risk Management meetings); Archives complaint records or returned products & retrieves information on previous investigations; Supports complaint database upgrades and conversions by providing input and performing system testing; Ensures accurate department procedures and work instructions are maintained; and support inspections by regulatory agencies (e.g. FDA, TUV) as requested

The Product Surveillance Analyst must be able to : Collaborate independently with other team members and departments needing product complaint information; Be able to conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints; Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management; Use procedures, judgment and experience to determine appropriate testing of returned products with minimal guidance; and be able to ascertain when additional support may be needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues)

Train others in Product Surveillance product complaint handling. Provide support to Legal Dept on product complaints. Support all Divisional initiatives as identified by divisional management and in support of 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. 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

Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment. Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees

Qualification

Medical device reportingComplaint handling investigationsRegulatory knowledgeCommunication skillsProblem-solving skillsOrganizational skills

Required

Bachelors Degree preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis. Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position or an equivalent combination of education and work experience

Knowledge of global regulations for medical device reporting and medical terminology is a plus

Strong written and oral communication skills are required

Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously

Good problem-solving and proficient computer skills are required

Multitasks, prioritizes and meets deadlines in timely manner

Strong organizational and follow-up skills, as well as attention to detail

Ability to maintain regular and predictable attendance