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Vacancy Details


Senior Regulatory Affairs Specialist - Galway - 102624

Contract Type: Permanent
Location: Galway
Date: 8/04/2019
Job Reference: 102624
Contact Name: Bimi Felix
Contact Email:

Job Description

Senior Regulatory Affairs Specialist - Galway - 102624
Senior Regulatory Affairs Specialist
Our client, a medical device company in Galway is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.
The Regulatory Affairs Specialist provides independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches.

Key Responsibilities
  • Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials. The role assists in the development of best practices for Regulatory Affairs processes.
  • Helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
  • Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (e.g. represents Regulatory in the complaint handling and field action process).
  • Manages the local site transition to the New Medical Device Regulation and supports the integration in the J&J regulatory organisation.
  • Develops labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations is required
  • Ensures compliance with regulatory agency regulations and interpretations.
  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Provides regulatory advice to project teams.
  • Guides conformance with applicable regulations in product development, support of claims and label content
  • Defines data and information needed for regulatory approvals. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
  • Assist in the development of product reimbursement strategies. Lead applications for product reimbursements in line with company strategies
  • Provides Regulatory Affairs support during internal and external audits
  • Represents Regulatory Affairs on cross-functional project teams

Essential Skills / Experience
  • Minimum education of degree in a technical field.
  • Minimum 6 years’ experience in the medical device industry, with at least 3 years in a position in regulatory affairs or related/equivalent field.
  • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
  • Experience of inspection by an external agency, such as the FDA.
  • Ability to work well under deadlines and pressure
  • Demonstrated track record in
    • Submission of licenses and authorizations for the maintenance of existing products
    • International registrations and dossiers
    • Execution of regulatory strategies that align with business deliverables

For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 086 8395533 /

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