Medical Device Regulatory Affairs SME

Boston, MA

Job ID: 124943 Industry: Med

 

Medical Device Regulatory Affairs SME

Environment:

Our client a large medical device company that manufacturers class 3 products.  

Principle Duties and Responsibilities:

The Regulatory Affairs Specialist supports regulatory compliance throughout the organization by performing the required activities that assure compliance with FDA regulations. The Regulatory teams needs support with PMA activities, FDA response letters, and engineering changes. They will be reviewing documents, writing regulatory assessments, and helping out with a product line transfer. They will provide regulatory support for new/modifications to product design/ project teams. Prepare and obtain clearance of product submissions according to their respective regulations. Prepare and submit Medical Device Reports and Vigilance Reports. Participate in the review of process/product changes, labeling, claims, complaints, etc., to determine the need for any regulatory activities and to ensure compliance to FDA and international requirements.

This person will be the only RA SME at this facility. They need to be motivated, hands on, and need little to none supervision.

Required:

Medical Device- 7-10 years

Regulatory Affairs- 7 years

Electromechanical products 

Class III experience 

Job Type: Contract 

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