Job Title [Quality Regulatory Administrator]

Job Title: Quality/Regulatory Administrator

Reports to: VP Quality Regulatory

Position Type: Full Time- Exempt


The Quality Regulatory Administrator will provide support to Katena’s global distributor network and the QA/RA team

Primary Responsibilities

  • Support global distribution network by resourcing and providing QA/RA documentation & records as required for in-country regulatory registrations, listings and licensing of Katena distributed medical devices.
  • Support international product distribution by resourcing and providing product specific QA certificates, as needed for various shipments.
  • Support QA/RA team in the maintenance of various QA/RA databases used to support product line registrations, certifications, licensing/listings, and distribution controls.
  • Support QA/RA team in compliation of data, generate various quality system / regulatory reports, presentations as needed for global regulatory needs.
  • Support QA/RA team in the ongoing supplier / distributor assessment, agreements and monitoring program.
  • Support QA/RA team with ongoing Quality Management System document / change control.
  • Monitor, research and resource various forms of product feed-back for Post-Market Surveillance purposes.
  • Support QA/RA team during quality system audits and 3rd party inspections.
  • Assist QA/RA team by maintaining various QA/RA Quality System files such as distributor regulatory files, product registrations / agreements and assessment files.
  • Support QA/RA Team in the maintenance of UDI program, internal and 3rd party product barcode databases.

Expertise: Knowledge & Skills

  • Detailed Oriented / Energenic /Self Motivated / Career Oriented person with exceptional organizational skills
  • Some working knowledge of Medical Device compliance (FDA 21 CFR 820) & ISO 13485.
  • Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative, distributors & management personnel
  • Proficient in Microsoft Office applications (advanced Excel, Word, PowerPoint)
  • Strong verbal and written Communication Skills

Required Education and Experience

  • Associate degree (AA) or equivalent from a two-year college or technical school, or six months to one year related experience and/or training, or equivalent combination of education and experience.
  • Some College preferred or 2-5 years’ experience in Med Device or QA/RA
  • Must be able to drive, own a car and be willing to drive to county courthouse for notary certifications.
  • Morris County Notary a plus

Other Duties

  • Backup/ team coverage of other functions such as:
    • Assistance with incoming product release activities
    • Assistance in reporting activities
    • Assistance in Power Point presentation development
  • Administrative support for Quality/Regulatory Team
  • Other projects and duties as assigned by to other departments with manager’s approval