PDS has the following open contract opportunity in Tucson, AZ:
SENIOR REGULATORY AFFAIRS SPECIALIST
STRONG PARTNERING SKILLS
MEDICAL DEVICE/HEALTHCARE/PHARMACEUTICAL/RESEARCH LAB BACKGROUND
REGULATORY DOCUMENTATION REVIEW
Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications.
Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
Responsible for maintenance of product technical files and for ongoing activities related to compliance with global directives and regulations.
Assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
Interface with regulatory authorities on regulatory and technical matters, as directed.
May provide regulatory support on project teams.
Assist in the creation of Operating Procedures and policy guidelines.
Assist in review of labeling changes, advertising and promotional activities, etc.
May assist as the internal regulatory consultant for on-market product issues.
Assist in review of proposed device changes.
May perform other duties as required or assigned.