Regulatory Affairs Associate / Clinical Trails
Regulatory Affairs Associate located in the Charllote, NC / Durham, NC area.  Candidate must have 2 years of related work experience in Regulatory Affairs, Quality Assurance and Clinical Research.Minimum Candidate Requirements:Ability to identify and interpret regulations, guidelines and pertinent information required to conduct clinical trials in US and Canada.Ability to prepare and submit regulatory documents required for approvals by Regulatory Authorities and Ethics Committees.Ability to identify, review and approve regulatory documents for site activation.Bachelor’s degree with at least 2 years of related work experience in Regulatory Affairs, Quality Assurance and Clinical ResearchSkills/Certifications/ Special Training Preferred:Regulatory Affairs Certification preferredExcellent communication and analytical skillsCandidates with device experienceCandidates with Clinical Trial Application&lt;x{(}&gt;(CTA)/Investigational Testing Authorization &lt;x{(}&gt;(ITA), IND and IDE submission experience• Education: Technical, BS or BSE preferred • Clinical study experience is a plus.
Title: Regulatory Affairs Associate / Clinical Trails
Salary: None
Description: Regulatory Affairs Associate located in the Charllote, NC / Durham, NC area.  Candidate must have 2 years of related work experience in Regulatory Affairs, Quality Assurance and Clinical Research.Minimum Candidate Requirements:Ability to identify and interpret regulations, guidelines and pertinent information required to conduct clinical trials in US and Canada.Ability to prepare and submit regulatory documents required for approvals by Regulatory Authorities and Ethics Committees.Ability to identify, review and approve regulatory documents for site activation.Bachelor’s degree with at least 2 years of related work experience in Regulatory Affairs, Quality Assurance and Clinical ResearchSkills/Certifications/ Special Training Preferred:Regulatory Affairs Certification preferredExcellent communication and analytical skillsCandidates with device experienceCandidates with Clinical Trial Application&lt;x{(}&gt;(CTA)/Investigational Testing Authorization &lt;x{(}&gt;(ITA), IND and IDE submission experience• Education: Technical, BS or BSE preferred • Clinical study experience is a plus.
Requirements: Mid-Senior level experience, Bachelor's Degree education
Fraudulent: No