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Gaillimh

    Principal Regulatory Affairs Specialist - County Galway, Ireland - Cpl

    Cpl
    Cpl County Galway, Ireland

    Found in: beBee S2 IE - 1 day ago

    CPL background
    Full time
    Description

    My client, a leading medical device manufacturer, are seeking a Principal Regulatory Affairs Specialist for their Galway site. Regulatory Affairs is a key function within the business and this role is supporting the Structural Heart business.

    Responsibilities

    · Develop robust regulatory strategies

    · Engage with regulatory agencies as the lead representative of the company

    · Resolve questions from regulatory agencies for changes to existing products

    · Lead regulatory filings to support submissions, license renewal and annual registrations.

    · Support manufacturing strategy via a robust change control approach

    · Mentor and coach more junior members of the department

    · Keep abreast of regulatory procedures and changes.

    · Develops internal procedures to ensure continuous regulatory compliance

    · Influences clinical evidence strategy to support labelling content, marketing claims and regulatory compliance.

    · Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.

    Requirements

    · Level 8 Science or Engineering Degree; Masters desirable

    · Regulatory experience in Medical Devices and / or Pharmaceuticals is required.

    · A Regulatory Affairs qualification is desirable.

    If interested please send your CV to

    #LI-EL2

    #CplEmerLong