VirtualVocations

Work from Home Part-Time Regulatory Affairs Assistant

Kelly Scientific Resources has an exciting administrative employment opportunity for an individual experienced in Regulatory Affairs (RA).  We are currently assisting the medical device division of a global Consumer Products company identify an individual to support their RA team in a pre-IDE FDA submission.

The selected candidate can work from their home office, but will be required to travel at least twice (1 time to the home base in Wisconsin, and another to Washington DC for the FDA meeting).

Below is the list of duties to be performed by the selected candidate. 

They require all candidates have some level of experience in Pre-IDE FDA submissions.  All candidates must also have experience working in support of medical devices.  The start date is ASAP, and will run for roughly 4 months at approximately 20 hrs/wk.

Duties to include the following:

1. Prepare documents, review materials and participate in FDA Pre-IDE meeting

2. Prepare briefing packages

3. Prepare slide decks

4. Participate in the scheduling FDA meeting per CDRH guidelines

5. Conduct internal reviews

6. Participate FDA meeting rehearsal in Washington DC

7. Attend and give presentation during the FDA meeting

8. Serve as the FDA meeting moderator

9. Take and review FDA meeting minutes

If you have experience in Regulatory Affairs, specifically in Medical Devices, have experience in pre-IDE submissions, and are looking for a WORTHWILE PT contract employment opportunity where you will be instrumental in TRULY MAKING a difference in the lives of individuals who benefit from the use of life saving equipment, APPLY NOW via the button below. 

Kelly Scientific Recruiters are actively are actively reviewing resumes received through the online application process. 

Job Qualifications/Requirements and Benefits

A minimum of 3 years experience in Regulatory Affairs, specifically in Medical Devices. Must have experience in pre-IDE submissions.

Employer Posted:Wednesday, August 27, 2008