Previous Job
Previous
RAD Analyst
Ref No.: 18-08666
Location: Raynham, Massachusetts
Start Date: 07/17/2018
To enter product approval requests into the buyers Product Registration 'Regulatory Approval Database' (RAD) database to enable product release to World Wide Markets, whilst maintaining complete regulatory compliance. RAD Analysts receive RAD Processing Packages from RAD Investigators and execute the entry and validation of approval data into the RAD system. RAD Analysts also act as a secondary review of the approvals.
  • Update request tracking processes to ensure workload and status is documented.
  • Enters, maintains and validates regulatory approvals in the RAD system.
  • Provides secondary review of approval requirements during data validation.
  • Performing special projects as required.
  • Assist RAD Investigator with approval investigations as required.
  • Perform other duties as assigned.

Qualifications:
  • A Bachelors degree is required.
  • A minimum of 2+ years of regulated industry experience is required.
  • Basic working knowledge of FDA and/or European regulatory requirements is required.
  • Experience with 510k's, Technical Files, PMA's and design dossiers is preferred.
  • Experience with US and EU regulatory requirements is preferred.
  • International experience outside of the US and EU is an asset.
  • The ability to develop and maintain excellent working relationships with regulatory personnel is required.
  • Ability to write, proofread and check documents for accuracy; ability to relate information to requirements; and ability to identify inconsistencies will be needed.
  • Proficiency in the use of technology including MS Office Software Packages and Internet for word processing, spreadsheet analysis, database analysis, Internet research, etc. will be required.
  • Excellent communication, organizational and problem-solving skills are required.
  • Must be able to work successfully within a team environment and as an individual contributor.