Regulatory Affairs

2 positions, on at the Manager level and at the Director Level.
Job Description:
Represent and provide post market regulatory support. Work with Manufacturing and Technical Operations to identify and prepare regulatory submissions to report post market product changes to Regulatory Authorities. Reporting includes PMA Annual Reports and 30-Day notices. Ensure changes requiring notification ex-US are communicated appropriately. Interact and communicate with FDA to ensure compliance to their requirements. Participate in Project Development Teams covering products. Provide premarket support working with development Core teams to prepare regulatory submissions (i.e. 510(k)s, Pre-IDE, IVDD technical file, etc.) and global dossiers for ex-US registration for new products.

BS in Chemistry, Biology, Biochemistry or engineering.

Typical experience: 8 - 10 years experience in Regulatory and Compliance activities for Medical Devices (For Director) 5-8 years for Manager
Ability to lead teams and work with other cross-functional groups to insure quality regulatory submissions. Working knowledge of Global Medical Device Regulations (FDA, IVDD, MED Dev, ISO, etc.)
Excellent written and oral skills. Experience in interacting with regulatory agencies and Notified Bodies.
Experience with preparing and filing regulatory submissions.

Category:	Manufacturing
	> Other Manufacturing
Location:	New Hartford, NY
County:	Oneida County
ZIP Code:	13413
Pay Rate:	Open
Job Terms:	full time
Company:	Staffworks Professional
Phone:	315-735-5050 x240
Fax:	315-735-1113