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Regulatory Affairs Specialist

  • Salary: Negotiable
  • Job type: Contract
  • Location: Dublin
  • Sector: Quality & Compliance
  • Date posted: 31/07/2017
  • Job reference: J364694A

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Regulatory Affairs Specialist - 12 month FTC

This position reports directly to the Regulatory Affairs Group Leader.

Job Summary

The regulatory affairs specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation.

Essential Job Duties And Responsibilities

Employees are expected to support the quality concepts inherent in the business philosophies of Lake Region Medical including a variety of job related tasks which may not be specific to this position profile.

Accountabilities include:

The Regulatory Specialist is responsible for:

  1. SupportingtheQA/RA Manager in ensuring continuous compliance with the following:
    • FDA Quality System Regulation 21 CFR 820 (QSR)
    • Medical Device Directive
    • Health Canada Medical Device Regulations
    • ISO13485 Medical Device Quality Management System
    • ISO14971 Risk Management for Medical Devices
    • Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards

  1. Regulatory Filings
    1. Compile regulatory strategies for proposed new products to outline the strategy for marketing the device in the relevant markets.
    2. Compile regulatory submissions for:
  • CE registration
  • 510(k) registration
  • Annual reports,
  • Supplements and registrations.
  • Keep up to date with current regulatory requirements and ensure that procedures are reflective of these requirements.

  1. Assist with preparation activities and activities during:
    1. Regulatory Body Audits (FDA inspections, ISO 13485 surveillance audits, other regulatory authorities as required)
  • Planning and Communication with Regulatory contact
  • Internal Planning and Communication & document co-ordination
  • Audit assistance for duration of audit
  • Communication & Feedback afterwards
  • Co-ordination of corrective action and response issuance

  1. Change Assessment

Regulatory Impact of Changes

  1. Assist the design and manufacturing group with assessing the regulatory impact (impact to product filings) for proposed changes to product design.
  2. Compile Regulatory Analysis Reviews as required to document these assessments.

  1. Other regulatory activities
    1. Lead regulatory activities relating to
  • Risk Management Activities
  • Clinical Evaluation activities
  • Post Market Surveillance

  1. Supporting Quality system improvements and regulatory activities concerning the Quality system.

  1. Be an active member of the Lake Region Medical Limited team and work closely with the design & development team to bring new products to market.

  1. Comply with the behavioural standards.

  1. Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements in your absence.

Skills And Knowledge:

  • Ability to communicate and work with people inside and outside the department.
  • Ability to supervise
  • Ability to co-ordinate, plan and organise

Minimum Education And Experience Requirements:

  • College graduate with Engineering or science degree or equivalent experience.
  • Qualified systems lead auditor.

  • 1-3 years experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment