Regulatory Affairs Specialist - Leader

Job Title – Regulatory Affairs Specialist
Job Location – Remote with some onsite at Pittsburgh PA (Monroeville)
Length – Contract (4-5 Months+)
Education: Bachelor's /Master's degree or equivalent. 
Significant leadership experience in role. 

 Work independently on Regulatory duties, processes and roles outlined below:
 1. Create and update European Technical File, Declaration of Conformity, and classification documents according to the new European Medical Device Regulations (EU MDR). Communicate identified gaps, track status through closure and work with the project team on update activities.  
 2. Review and approve product labeling plans, labeling, and marketing communications 
 3. Support EUDAMED database data collection and uploads 
 4. Support QMS system updates for compliance with the EU MDR 
 5. Support internal and external quality audits, as needed. 
 6. Provide regulatory training and guidance to assigned medical device new product development and sustaining projects as it relates to EU MDR
Kushal Shah
APN Software Service INC
609-357-9180 (Direct)

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