Regulatory Affairs Officer

Job type:
on-site
Start:
n.a
Duration:
n.a
From:
Vivid Resourcing
Place:
Overijssel
Date:
07/08/2016
Country:
flag_no Netherlands

Project description:
Warning
This project is archived and not active any more.
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  • Monitor and report status of MMD projects regarding progress against task order milestones, sponsor objectives, resource utilization and budgets;;
  • Oversee the execution of EU vigilance and field safety corrective actions;
  • Oversee the execution of EU device and authorized representative registrations;
  • Establish and maintain ongoing Sponsor relationships by serving as primary contact for Sponsor and internal project team members;
  • Interact with appropriate national/regional regulatory agencies;
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
  • Provide regulatory advice and guidance to internal and external teams to ensure compliance with appropriate national/regional regulations and requirements;
  • Present during bid defenses, general capabilities meetings, and audits;
  • Identify areas of improvement to project management processes and documentation, and implement changes as necessary; and
  • Develop and mentor employees and serve as resource for all MMD staff.