Regulatory Affairs Specialist (133558-560)

Responsible for preparation of documentation necessary for regulatory submissions and submission of applications to FDA, TUV and other regulatory bodies.

Responsible for some compliance and GMP Program activities within the company, assisting in meeting various government regulations, and coordinating voluntary standards activities: USA, Europe and other International Sites. Responsible for routine regulatory affairs functions.

1. Provide clinical and regulatory support to cross-functional teams during product development cycles.
2. Prepare and submit registration and technical information in support of international regulatory requirements and European Notified Bodies.
3. Prepare and submit FDA submissions (IDEs, 510(k)s, PMAs), facility listing, device registrations and other submissions as needed.
4. Assist in ensuring compliance with GMP (U.S) and EN46001 (European) requirements throughout the manufacturing facility.
5. Participate in Quality Training Programs.
6. Monitor clinical studies and maintains required documentation (as necessary).
7. Consults with surgeons to gain knowledge of the clinical problem and potential use of device.
8. Reads and understands literature and becomes knowledgeable in alternative therapies.
9. Support customer service and sales reps with information required to satisfy customer requests.
10. Assist Senior Regulatory staff during FDA establishment inspections as required.

Required Skills:

B.S. in Basic Science, Engineering, or Health Professional Degree (R.N., P.A.) or equivalent. Minimum of two (2) years experience in regulatory, research, or quality assurance field required. Must possess knowledge of FDA GMP/QSR requirements.

Please apply online at:
http://hostedjobs.openhire.com/onlinejobs/jobs/submit.cfm?fuseaction=dspjob&jobid=133558&company_id=15560&version=1&jobboardid=24