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International Regulatory Affairs Specialist

Location:Morrisville, NC
Benefits:Comprehensive Benefits Package with 401K
Employment Type:Full Time
Description:The International Regulatory Affairs Specialist is responsible for pre-market clearances, registration of products to international and US medical device regulations, and post-market support of TransEnterix products The position is responsible for strategic regulatory planning for new and revised product introductions into current and emerging markets. The position will develop, document and manage medical device submissions to regulatory authorities for pre-market clearance and registration.

Regulatory duties include evaluation of current and changing international medical device regulatory policies/regulations and the implementation of regulations into company policies and procedures.

The position is responsible for identifying international vigilance requirements and supporting vigilance reporting in international territories.

The position will assist in the development and control of labeling to meet international requirements.

The position will support management of exporting activities.

The position will support domestic regulatory functions as assigned.

Project a positive and supportive approach to R&D, sales, marketing, and other related functions to assure compliance in job related areas.
Duties:Develop and implement policies and procedures for Company compliance and regulatory market clearance to medical device requirements such as ISO 13485, EUís Medical Device Directive, and clinical regulations including ISO 14155. May include other international regulations as applicable.

Regulatory strategic planning, pre-market clearance, annual product and facility registrations for international territories.

Evaluate and document regulatory requirements related to verification/validation study inputs and preclinical and clinical study inputs necessary to achieve international pre-market clearance.

Review changes in regulatory landscape and report for management review. Evaluate regulatory changes and identify action plans to assure company compliance to changing regulatory requirements. Assist in the implement plans via procedural changes or other actions as needed. Assist in the communication of regulatory requirements to other departments and employees.

Support corporate and department objectives especially those related to product market introductions assuring that goals are completed within specified timeframes.

All Other Essential Duties as directed.

Requires a bachelor's degree in a related technical field, engineering preferred, and at least 6-8 years of experience in the medical devices field.

Familiar with a variety of the field's concepts, practices, procedures and regulations. Regulatory certification required or regulatory related degree required.

International medical device clearance and registrations desired especially with regard to the European Union, Middle East, South America and limited pacific rim territories including Taiwan, South Korea, etc.

Medical device regulatory experience desired; experience with products containing software, hardware, platform/systems level products, and surgical devices desired.

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