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!
- 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.
- 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