Regulatory Affairs Consultant

Galway  ‐ Onsite
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Keywords

Description

Major Responsibilities:
  • European Directive

    • Formulate, develop and implement a program to enable all CE marking registrations are completed efficiently and to an agreed schedule
    • Support a roll out program for existing products and new launches
    • Work with the RA colleagues around the world to ensure clear communication of requirements to meet timely worldwide registration
    • Implement the creation and development of Technical files and Design Dossiers to meet the requirements of the Medical Devices Directive and guidance documents.

  • Label Copy

    • Review all baseline and translated (new and on-market) labelling marketing and training materials for regulatory compliance within EU Member States. Where appropriate ensure regulatory compliance is met for those countries outside of the EU.

  • Projects

    • Provide timely guidance and support to project development teams to ensure project development and documentation will meet the regulatory requirements in target countries.
    • Undertake specific projects as assigned by the line manager to the agreed timescales.
    • Ensure that all documentation is correctly completed to a high standard of clarity.

  • General

    • Maintain awareness of regulations and guidelines governing the company and communicate their impact on the registrations.
    • To open and maintain regular communications with any contacts requiring any regulatory involvement.
    • Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Corporate requirements and applicable regulation
    • Maintain awareness and ensure compliance with site EHS policy and procedure


    Education:

    Educated to degree level or equivalent preferably in a scientific or engineering discipline e.g. or bioengineering etc. with minimum two to four years of regulatory submissions experience in Medical Device Directives.

    Background:

    Knowledge of regulatory requirements for ISO 13485, MDD (93/42/EEC) and FDA Quality Systems Regulations would be advantageous but dependent on background and experience, not essential. Experience within a medical or healthcare manufacturing industry preferably in a regulatory role. Good written and oral skills, good interpersonal skills and an ability to work on their own initiative and as part of a multi-disciplinary team. Good organisational skills, an ability to work under pressure and communicate effectively with people at all levels throughout the organisation.

    The above background prerequisites are required to provide a level of knowledge and experience to complete registrations and associated duties.
    Start date
    01/2015
    Duration
    12 months
    From
    Real Staffing
    Published at
    03.12.2014
    Project ID:
    817392
    Contract type
    Freelance
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