Analyst I Postmarket Surveillance
$50,700–$101,300 year
On-sitePlano, Texas, United States
Plano, Texas, United StatesOn-siteFull Time$50,700–$101,300 yearBachelors DegreeLarge
Full TimeBachelors DegreeLarge
Job Summary
Manage worldwide product complaints and events by receiving reports, investigating findings, and entering data into the complaint database. Independently determine if medical device reports are needed for regulatory agencies like the FDA and prepare customer letters with analysis findings. Coordinate product testing, track returned items, and collaborate with cross-functional teams on evaluation trends. Maintain accurate department procedures, support regulatory inspections, and train others on complaint handling protocols.
Required Qualifications
- Bachelors Degree preferably in the healthcare or science fields
- 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis
- Strengths suitable for this position or an equivalent combination of education and work experience
- Knowledge of global regulations for medical device reporting
- Medical terminology
- Strong written and oral communication skills
- Ability 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
- Experience working in a broader enterprise/cross-division business unit model
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- 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
- Good correctable vision
- Hand/eye coordination
- Voice and hearing for discussions with other employees
- Compliance with U.S. Food and Drug Administration (FDA) regulations
- Compliance with other regulatory requirements
- Compliance with Company policies, operating procedures, processes, and task assignments
Desired Qualifications
- Experience supporting complaint handling investigations
- Experience with medical device reporting
- Experience with product analysis
- Experience in a healthcare field
- Experience in a science field
- Experience in a broader enterprise/cross-division business unit model
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