Job Summary

A staffing agency is seeking a Remote Medical Devices Regulatory Affairs Specialist.

Candidates will be responsible for the following:

• Obtaining and maintaining world-wide approvals; management of regulatory clinical trials
• Contributing to global regulatory strategy and act as the regulatory voice for cross-functional discussions and corporate processes. •
• Facilitating meetings with regulatory agencies to affect overall product development

Required Skills:

• BS/BA and 6+ years of experience in Regulatory Affairs
• Strong medical device manufacturing experience
• Experience covering several regulatory areas
• Experience device registrations, quality system requirements, design controls, etc
• Experience in direct interaction with domestic and international regulatory agencies