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Senior Regulatory Affairs Specialist

Galway  ‐ Onsite
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Keywords

Description

KEY RESPONSIBILITIES

  • Prepare FDA submissions to support US clinical activities, IDE supplements, IDE annual reports, Investigator Reports, and Pre-Subs.
  • Prepare technical submissions in accordance with current Medical Device Directive requirements, including Annual reports to Notified Bodies, Design Dossiers, Substantial Change Notifications and Clinical Evaluation reports.
  • Compile/review regulatory documentation to support IRB & Ethics Committee submissions in US and Europe.
  • Assist/prepare clinical reports from IDE, OUS and Post Approval Clinical Studies.
  • Prepare and manage international regulatory submissions in accordance with commercialisation plan.
  • Review and approve product labelling changes, promotional literature and marketing materials prepared by Company and its distributors.
  • Provide regulatory oversight of customer complaint handling procedure.
  • Provide input to regulatory aspects of change control, non-conforming process.
  • Participate as a Clinical Project team member to provide regulatory oversight of clinical operations including provision of safety reporting and vigilance support.
  • Provide a regulatory interface to COmpany's clinical and commercial operations.
  • Assist with training in Quality System Regulation, ISO Standards and other International Regulations
  • Manage assigned aspects of the Quality System as required.


    • SKILLS & EXPERIENCE
  • Life Sciences or Engineering Degree
  • Minimum 5 years' experience as an RA Engineer/Specialist in medical devices, ideally in the cardiovascular field.
  • Clinical study experience is essential with experience of ensuring regulatory compliance across multiple vendors desirable.
  • Experience in all of the areas set out in the key responsibilities.
    • Start date
    02/2015
    Duration
    6 months
    From
    Real Staffing
    Published at
    07.02.2015
    Project ID:
    846680
    Contract type
    Freelance
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