Medical Device International Regulatory Affairs Specialist

Philadelphia, PA

Job ID: 122833 Industry: Med

 

Medical Device  International Regulatory Affairs Specialist

Environment:
Medical device leader in manufacturing invasive and catheter-based technologies for cardiac surgeries. They are looking for a Regulator Affairs specialist to assist with a global project.

Job Duties/Responsibilities:

This position is responsible for determining current medical device regulatory requirements for our client’ s products. They are responsible for preparing documents and or submissions required to obtain clearance or approval for products worldwide. They will be working with current medical device products that need approval in Europe and Japan. They will demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. They need to have current knowledge of global medical device regulations pertaining to the distribution of products. Past experience with catheter-based products is a plus.

Required Skills:

Medical Device

Global Regulatory Affairs

Submissions

Job Type: Contract 

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