Regulatory Affairs Specialist

• Responsible for the planning of regulatory activities. Develops and implements strategies with the goal of market access in identified geographies
• Acts as a core team member on development teams as Regulatory Affairs subject matter expert providing feedback and guidance throughout the product development lifecycle
• Plan, coordinate and prepare document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and other global regulatory agencies
• Negotiate and interact with regulatory authorities during the development and review process
• In collaboration with R&D maintain list of applicable standards
• Responsible for regulatory compliance and adherence with regulatory requirements
• Perform gap assessments and communicate standard/regulation changes and updates to staff and management as needed
• Coordinate with the clinical team on IDE supplements and/or amendments to update clinical investigational and protocol information as needed
• Evaluate proposed product changes and prepare ECO Regulatory Plans
• Provide regulatory support and guidance to clinical, R&D, operations departments, and project teams and staff as needed
• Interpret Company Policy
• Participate in internal and external audits as needed
• Mentor junior members of the Regulatory team

• Global regulatory reporting for company products
• Vigilance reporting
• Liaison with regulatory authorities as needed to resolve key regulatory issues

Mploy