Job Opportunity for Documentation specialist at Tarrytown, NY with direct client. Please go through Detailed Job description below.
Duration: 6-9 months. Contract only
Here is a brief Job description:
Accumulates statistical data and performing special research, verification and data gathering projects on request. Meets with Quality Assurance personnel to establish production requirements for material presented to customers and others. Receives, processes, records, coordinates and distributes data.
Specifically, the candidate must be familiar with IVDR, regulatory environment and clinical studies. Must possess ability to efficiently do literature searches to support technical files (post market surveillance, regulatory intelligence).
The selected contractor will be requested to put together clinical document supporting respective areas of IVDR.
· Track progress to confirm all deliverables are met and are in compliance with IVDR requirements
· Capture gaps, and manage activities to verify closure
· Manage Teamspace for her/his files; notify RA when each file is complete
· Support the IVDR Implementation clinical team for completion of Technical Files
· B.A./B.S. or equivalent; typically 5-10 years experience
· Strong IVDR and / or MDR understanding and working knowledge
· Knowledge and experience with global registrations of in vitro diagnostic devices or medical devices a plus
· Strong technical background, preferably in the in vitro diagnostics or medical device industry
· Strong analytical skills to assess situations and drive decision making
· Strong interpersonal, communication and organizational skills required
· Must be able to set priorities as well as adapt to changing priorities
· Ability to function in a changing, high-impact position, with deadline and resource constraints
· Demonstrated effective written and oral communications skills. Familiarity with key software and decision making tools
If you have the above qualification and interested to apply please reply with your updated resume, contact no. and expected pay rate and I will contact you to discuss further.