Quality Manager - Post Market Compliance - (US-MA-Dorchester Center - 02124)

Minimum Education: None
Jobcode: L:106764208
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DUTIES AND RESPONSIBILITIES:
 

Ensures that postmarket surveillance tasks are completed as required by company policies and procedures, as well as compliance with applicable industry regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485-2003, etc)
Accountable for managing thorough, accurate, and timely closure of product complaint files.
Ensure timely and robust content of investigation reports for returned product.
Professional contact with customer to gain insight into each product complaint event.
Ensure product complaint records, MedWatch reports (FDA Form 3500A), and applicable product complaint handling documents are complaint with Good Documentation Practices (GDP).
Prepare and submit FDA MedWatch , Quarterly ASR, and Baseline (FDA Form 3417) reports within the mandated timelines.
Prepare and submit Vigilance reports (MEDDEV) and Canadian Medical Device Problem reports (MPR) within the mandated timelines.
Performs other related duties as assigned by management.

 
 
Education/Certification: 

Bachelor's degree with demonstrated experience working in a regulated environment -- a minimum of 5-10 years experience or
Associates degree with at least 10-15 years of documented experience in a Medical Device environment.
In depth and demonstrated knowledge of FDA 21 CFR Parts 820.198, FDA 21 CFR Part 803, ISO 13485, Vigilance Reporting, Health Canada reporting assessment requirements, and ISO 14971


Previous experience with FDA inspections and Notified Body audits is a requirement .