Medline Industries, LP is looking to solve problems related to post-market surveillance, adverse event reporting, and product safety by hiring a clinical resource to assess incoming complaints, determine reportability, participate in investigations, and submit adverse event reports.
Requirements
- Demonstrated ability to analyze and report data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
- Experience applying knowledge of FDA and international Health Authority reporting requirements.
- Understanding of the clinical environment and product work flow.
- Familiarity with the application of medical device as it relates to patient safety.
- Knowledge of clinical workflow and product use in assessing incoming complaints and hazards.
- Assist in post-market reportability determination.
- Participate in clinical investigations for reported product incidents and submit adverse event reports.
Responsibilities
- Identify and evaluate complaints which affect patient safety.
- Prepare and submit Medical Device Reports (MDRs) to the FDA.
- Process MDRs and coordinate international report filing with local health authorities.
- Review, evaluate and classify potential reportable customer safety complaints.
- Conduct risk analysis and design development modifications for new and existing products; provide clinical insight, review, and risk controls leads.
- Analyze patient safety and risk data.
- Identify product safety issues; triage complaints for further investigation.
Other
- Bachelor's degree in medical science, health sciences or healthcare related field and at least 2 years of clinical, medical device risk management, or pharmaceutical risk management experience OR Healthcare provider certificate/licensure.
- Communication skills to convey technical information to non-technical audiences.
- Skills and ability to work with cross-functional teams and facilitate teams to identify and implement solutions to complex problems.
- Time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
- Ability to accomplish goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.
