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Quality/Regulatory Associate

Job Code: 48819757
Job Location: Middlesex County, MA
Category: Quality Engineering
Last Updated: 01/15/2017
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The Quality/Regulatory Associate will provide administrative support to Regulatory Affairs performing activities associated with preparing and reviewing documentation for obtaining market clearance in US, EU, and Rest of World (ROW) markets. Also, provide support to Post Market QA performing activities associated with receipt, processing, coding and closure of customer product complaints.
 
Regulatory Duties:

  • Actively contribute to the development and implementation of regulatory strategy for assigned projects and programs;
  • Assist with preparing and filing regulatory applications in the US, EU, and ROW countries. Support the creation, review or revision of regulatory documentation;
  • and more.

 
Post Market QA Duties:

  • Initiate complaint files and document complaint and regulatory reportability assessment within complaints database per Company's procedures, GMP's, 21CFR803,820,ISO13485, EU Medical Device Directive (MDD) 93/42/EEC and other applicable national regulatory requirements;
  • Process warranty returns received in the PMQA lab, in accordance with the company warranty program guidelines while maintaining adherence to all applicable PPE and Blood Bourne Pathogens guidelines;
  • Sterilize returned product as necessary when sterility of the item is not established;
  • and more.


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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