Associate Biomedical Engineer /MDR Specialist x2 19785

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

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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

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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 Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance