International Regulatory Affairs Associate (IRC1311)

Prepare regulatory correspondence and reports to the company• Ts Latin America distributors andCanada. Maintains international regulations, and approval lists for international product approvals based on U.S. and International requirements as defined by FDA Regulations ISO 13485:2003 Standards, European Medical Device Directives, Canadian Medical Device Regulations and applicable country product registration regulations -.    Prepares Latin America Distributor Authorization Letters (signed by Integra Corporate Senior Management) -.    Coordinates the notarization and legalization of regulatory documents -.    Maintains database ofLatin Americadistributors and registrations -.    Maintains and updates lists of national and international regulations, standards and FDA guidance documents and the associated Standard Operating Procedures -.    Prepares Certificates to Foreign Government, Certificates of Free Sale, and Declarations of Conformity for Latin America andCanadaas requested -.    Tracks regulatory requests from Latin America Distributors and maintains lists of product approvals -.    Communicates withLatin AmericaSales Managers and Distributors -.    Gathers data and assists with the preparation of regulatory submissions to Latin America andCanada -.    Participates in regulatory agency audits and responses to support audit findings or other actions related to such audits as needed -.    Participates in training and education seminars as appropriate to learn regulatory requirements -.    Reads related regulatory publications and documents to stay informed about current regulatory actions-.    Performs other duties as required.

Please refer to job code integrals-1311 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Plainsboro, NJ
County:	Middlesex County
ZIP Code:	08536
Pay Rate:	Open
Job Terms:	full time
Company:	Integra LifeSciences
Phone:	email only please
Fax:	email only please