The Regulatory Associate is responsible for activities which lead to, and maintain regulatory approval to market devices. Additionally, the Associate is responsible for assessment of device changes for regulatory implications.
KEY RESPONSIBILITIES
• Develop strategies for regulatory approval of medical devices.
• Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
• Communicate submission and/or advertising and promotion requirements to product development teams.
• Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
• Coordinate IFU development activities.
KEY RESPONSIBILITIES
• Develop strategies for regulatory approval of medical devices.
• Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
• Communicate submission and/or advertising and promotion requirements to product development teams.
• Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
• Coordinate IFU development activities.
· Process change orders.
To apply send resume to : cathyc@emersonconsultants.com
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