Regulatory Affairs Assistant

Regulatory Affairs Assistant

Regulatory Affairs Assistant

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Accentuate Staffing is assisting a leading medical device manufacturer in RTP, NC with their need for a Regulatory Affairs Assistant.  This is a 2 year contract opportunity!

Responsibilities:

  • Exporting labels & IFUs in PDF from Agile to bundle with registration packages for submissions.
  • Tracking progress of submissions into and from countries, from beginning to end/closure of submissions.
  • Researching labels and IFU in Agile to collect, record, and reconcile regulatory details to assist the BU RAS team with redlines.
  • Own all aspects of the registration tracking, recording, and reporting workbooks for product groups.
  • Assist RAS team in communication and open action items, follow ups, etc. per the project timeline.
  • Support the BU RAS in physical regulatory package submission shipments to countries/dealers.
  • Log-in licenses/codes into RA registration database.
  • Support RAS in additional administrative tasks as needed.
  • Collecting and maintaining invoices relating to registration submission requirements; CFGs, legalization of docs costs.
  • And any other extended project duties for BU RAS team and the project manager.

Requirements:

  • Strong Organizational skills.
  • Strong work ethic that encompasses reliability and trustworthy; Be on-time to work, meetings, task due-dates, and honesty.
  • Strong listening and comprehension, processing, and documenting project activities details.
  • Awareness of possible issues, using appropriate judgement of when to escalation obstacles.
  • Solid business communication and relationship skills (verbal and written) to work in a team-oriented environment.
  • Strong ability in multi-tasking, meeting deadlines, and detailed oriented.
  • Strong MS Excel software skills (data manipulation, reconciliation, VLookups, tables, charts).
  • Computer / Technical (working knowledge with MS Outlook, Word, and Power Point).
  • Minimum 2 years of college