US Director, Regulatory Affairs

JOB OVERVIEW:

Ensure Company is operating within the FDA requirements applicable to medical device manufacture and sales within company policies and guidelines, SOP and quality system.

RESPONSIBILITIES:

1. Regulatory

• Prepare, submit and maintain proper documentation for market clearance (FDA 510(k)) for new and existing Class II and Class III medical devices.
• Ensure all products are properly registered with FDA.
• Manage or Co-manage Company’s External and Internal Audit programs – SGS and FDA QSR.
• Manage Company’s products compliance to FDA UDI regulations.
• Ensure that Company products meet national regulatory requirements for manufacturing, distribution and sales.
• Maintain Temporary Import Bond program for products that are export only.
• Ensure that FDA Establishment Registration Listings are maintained, renewed and up to date for Company, Inc, Company, Ltd (Wokingham and Guernsey), Company, UAB (Lithuania) and Company Medical Apparatus, CO Ltd (Changzhou, China)
• Function as Official Correspondent and U.S. agent for the FDA for Company Inc, Company Ltd (Wokingham and Guernsey), Company UAB (Lithuania) and Company Medical Apparatus, CO Ltd (Changzhou, China)
• Provide customers with product registration information and technical data.
• Act as a resource for all Customer service personnel in handling customer queries.
• Any other duty or responsibility deemed by Management as required to maintain compliance with company policies, quality systems, and/or applicable laws or governing authorities.

2. Management Representative
   • To make monthly reports to Senior Management regarding status of all current regulatory processes.
   • To report on the performance of the Regulatory updates at semi-annual Management Review Meetings.

3. Customer Service
   • Provide customers with product registration information and technical data.
   • Act as a resource for all Customer service personnel in handling customer queries.

4. Production
   • To ensure local assembly operations and products meet all regulatory requirements.

5. Miscellaneous
   • Setting department aims and communicating accordingly.
   • Maintain competency in the Quality functions to be able to provide backup within the Quality Department.