Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. This is a 6-month contract working 100% remote.
You will be responsible for submitting change notifications, and updating documentation changes to legal entities.
Schedule : Monday thru Friday 8am to 4 : 30pm
Compensation : $20-22 / hr
- Submit change notification to multiple Notified Bodies
- Submit change notification to both EU Authorized Reps
- Submit Change notification to all international Authorized Reps
- Submit change notification to all international Distributors
- Update Technical Documentation for address and manufacturing changes of 2 legal entities The more detailed requirements of these activities are below;
- Work cross functionally to draw up details of manufacturing and address changes
- Track and follow-up communication with all international Distributors and Authorized Reps
- Update international licenses as required by international Distributors and Authorized Reps
- Review and approve Change Orders regarding manufacturing and address changes for both businesses
- Represent RA in Project Safari meetings
- Update clinical, post-market, summary of technical documentation and input any new documents from cross-functional teams into Technical Documentation
- Submit Label Checklists to labeling team
- Reserve and apply new UDI for address and manufacturing changes
- Track and follow-up communication of changes with all State License bodies for both businesses Qualifications / Requirements
- Must have experience using Office 365; Outlook, Word, Excel and Access
- Must work independently and productively with minimal supervision
- Previous medical device experience in a Regulatory Affairs capacity
- Previous experience registering medical devices internationally and the EU
- Great understanding of FDA CFR relating to med device and med device registration
- Previous experience drawing up med device Technical Documentation
- Preferred experience with state licensing bodies
- Strong attention to detail
- Enthusiastic about learning
- Self-Motivated and team player
- Critical thinking & Analytical skills
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