Product Compliance Associate

Marlborough, MA

Posted: 07/12/2019 Employment Type: Contract Industry: Life Sciences Job Number: 229900

Projected Description/Purpose of Role:

The Product Compliance associate is responsible for the execution of product complaint handling and regulatory assessment activities while insuringcomplaint handling tasks are completed as required and compliant to internal procedures and industry regulations

Job Description:

-Follow current policies and procedures to ensure compliance with all US and international regulations relating to complaint reporting

-Coordinate complaint data in the complaint database within specified database roles, such as Event Director, Device Tech, and Device Case Assessor once training has been completed for the specific role

-Determine if the complaint involves a reportable adverse event and report to manager

-Sent a complaint acknowledgement of receipt letter to patients, caregiver, etc.

-Work with warehousing department or front desk personnel to obtain returned devices 

-Processing of returned goods for evaluation

-Perform decontamination process for all returned devices that leave the product compliance department

-Forward completed investigation forms to Product Compliance Manager or designated individual for completion and closing of the complaint.

-Maintaining Decontamination / Evaluation Lab and Dept. storage areas

-Shipping product return kits as necessary (weekdays)

-Shipping dermatological product samples upon request (weekdays)

-Shipping EZ-Fills replacements within 24 hours of request (weekdays and 2 hrs on Sat's)

-Occasionally will contact patients, Health Care Professionals, or Valeritas Sales Reps for follow up

-Occasionally will contact Valeritas Customer Care for clarification of case information when necessary

-Tracking of all fulfillment item (EZ-Fills, Product Return Kits, and complimentary samples)

-Ordering all supplies

-Ensuring returned product investigations are completed in a timely manner 
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs: