Medical Device Regulatory Affairs Specialist

Richboro, PA

Job ID: 124029 Industry: Med
 
 

International Medical Device 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 will be fulfilling the Regulatory role for the company by reviewing SOPs, risk assessment, risk analysis,  supporting the design team, validation, MDRs, and complaints.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:
  • Medical Device
  • Global Regulatory Affairs
  • Submissions

Job Type: Contract 

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