July 18, 2018 – GDS Compliance Process and Standards – p b Job Responsibilities: /b /p ul li Review controlled process documents to ensure submitted procedures are compliant and meet the requirements
August 21, 2017 – Regulatory Compliance Associate – II – p b Description /b : /p ul li Regulatory Compliance Specialist – Electronic Systems /li /ul p b Essential Duties and Job Functions: /b /p
August 10, 2017 – Clinical Trials, Compliance & Safety – p b Job Description: /b /p p b Must Have Skills (Top 3 technical skills only) * /b /p ul li Strong understanding of Interactive Voice
April 6, 2017 – Regulatory Compliance – p b Responsibilities: /b /p ul li Process or Receive/Record/Review complaint information. /li li Ensure the accuracy and completeness of
April 6, 2017 – Regulatory Compliance, Medical Device – Responsibilities: Process or Receive/Record/Review complaint information.
Ensure the accuracy and completeness of initial information from the Complaint Intake Forms or other complaint notification communications.
Enter/Update complaint information into complaint management software.
Initial determination if a product issue is considered a valid complaint based upon company’s definition. Evaluate complaints to determine whether an adverse event report/Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting (93/42/EEC) and any other worldwide regulatory requirements.