Review and manage medical device complaints to determine FDA reportability and support compliance efforts.

Job Requirements:

Bachelor’s degree (required)

Previous experience with Medical Device Reporting (MDR)

Background in nursing or healthcare profession

Experience working with a medical device company

Preferred Skills:

Familiarity with FDA reporting regulations and complaint handling procedures

Strong documentation and communication abilities

Experience coordinating with field service or clinical teams

Job Responsibilities:

Review and document incoming medical device complaint information

Assess complaints to determine if FDA reporting is required

Contact field personnel to gather additional details for complaint investigations

Maintain accurate and thorough complaint records in compliance with regulatory requirements

Support internal teams in interpreting and applying MDR regulations

Collaborate with quality and regulatory teams to ensure consistent reporting practices

Pay Details: $25.00 to $33.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance