Regulatory Affairs Specialist, ASLA

The Regulatory Affairs Specialist ASLA will be responsible for directing and providing information and support on regulatory activities necessary to obtain and maintain regulatory approvals outside of the United States for Teleflex Medical group products. Markets included are Asia, Pacific Region and South/Latin America. 

Specific responsibilities will include the coordination of foreign licensing and registration; preparation and assembly of documentation required to register Teleflex Medical group products in foreign markets and the creation and updating of technical files and design dossiers.  This position will be responsible for responding to customer and distributor requests for regulatory inforation and for ensuring that customer requests are effectively handled in a timely manner.

The Regulatory Affairs Specialist ASLA must always be informed of changes with respect to the Medical Device Directive as well as must stay abreast of evolving and changing regulatory requirements in foreign markets. The incumbent will serve as an information resource and liaison for international sales and marketing.

B.A. or B.S. in Life Sciences and three to five years medical device experience in Regulatory Affairs are required.  Knowledge and experience in one or more essential regulatory areas and marketing approvals; change assessment; advertising and promotional labeling; and quality systems is also required.

 

 

Preferred Qualifications

B.A. or B.S. in Chemistry, Life Sciences or Engineering.  Eight years medical device experience in Regulatory Affairs.