Regulatory Affairs Associate

1 week ago


Irvine, California, United States Marquee Staffing - OC Full time
Job Responsibilities:

As an Associate Complaint Management Specialist, your primary responsibility will be to support event reporting and investigation procedures related to medical device complaints.

You will work closely with territory managers and clinical specialists to acquire relevant complaint information and coordinate with internal departments to incorporate vital input into complaints reports.

Your duties will include generating and submitting medical device event reports to appropriate authorities and government agencies as required by applicable laws and regulations. You will also respond to inquiries regarding medical device report submission associated with device malfunction or serious injury.

You will ensure timely processing of complaints and participate in inter-departmental cross-functional projects.

The estimated annual salary for this position is around $70,000, based on experience and qualifications.

Requirements:
  • Bachelor's degree or higher in a related field
  • Strong knowledge of medical device reporting regulations and medical terminology
  • Excellent organizational skills and attention to detail
  • Able to perform job functions with minimal supervision


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