Adverse Events, Clinical Data, Cross-Functional, Documentation, Event Management, Maintain Compliance, Medical Equipment, Medical Office Administration, Pharmacovigilance, Quality Management, Regulatory Reports, Surveillance
Required Qualifications:
- Bachelor's degree required.
- 1–3 years of relevant experience.
- Medical Device Reporting (MDR) experience.
- Complaint handling experience.
- Knowledge of regulatory compliance.
- Strong analytical and critical thinking skills.
- Excellent organizational and time management skills.
- Strong written communication.
- Attention to detail.
- Ability to manage multiple priorities.
- Medical device industry experience.
Preferred Qualifications:
- Clinical background (RN or Healthcare Professional).
- Biomedical Engineering background.
- Experience in a regulated environment.
- Knowledge of quality systems.
- Experience with adverse event reporting.
- Cross-functional collaboration experience.
Description:
- Support Medical Device Report (MDR) activities.
- Review and process complaint records.
- Manage adverse event reporting.
- Monitor medical device surveillance.
- Maintain MDR and ADE records.
- Review clinical safety data.
- Prepare safety summaries and reports.
- Ensure regulatory compliance.
- Support complaint investigations.
- Collaborate with cross-functional teams.
- Maintain quality documentation.
- Support regulatory reporting projects.
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Three Point Solutions, Inc.