International Regulatory Affairs Associate (IRC1291)Posted: November 23, 2009
Prepare regulatory submissions, correspondence and reports for the company• Ts Asian distributors. 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 and applicable country product registration regulations * Prepares Asia Distributor Authorization Letters (signed by Integra Corporate Senior Management) * Coordinates the notarization and legalization of regulatory documents * Maintains database ofAsiadistributors and registrations * Maintains and updates list of international regulations and guidances, as required for the preparation of Asian submissions * Prepares Certificates to Foreign Government, Certificates of Free Sale, and Declarations of Conformity forAsiaand as requested * Tracks regulatory requests from Asia Distributors and maintains lists of product approvals * Communicates withAsiaSales Managers and Distributors * Gathers data and assists with the preparation of regulatory submissions toAsia * 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-1291 when responding to this ad.
| Category: | Biotech/Pharmaceutical |
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> 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 |
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