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Regulatory Affairs Specialist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Wexford
  • Sector: Science
  • Date posted: 28/08/2017
  • Job reference: J370715A

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REGULATORY AFFAIRS SPECIALIST

DESCRIPTION

Our client, a Medical device organisation, is currently seeking an experienced Regulatory Affairs professional to join their team. This is a permanent opportunity.

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.

The Regulatory Specialist is responsible for:

  • Ensuring continuous compliance with the following:
    • FDA Quality System Regulation 21 CFR 820 (QSR)
    • Medical Device Directive
    • HealthCanadaMedical Device Regulations
    • ISO13485 Medical Device Quality Management System
    • ISO14971
    • Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standard
  • Assistance with regulatory submissions for:
    • CE registration
    • 510(k) registration
    • Annual reports,
    • Supplements and registrations.
  • Assist with preparation activities for:
    • FDA inspections,
    • ISO 13485 surveillance audits
    • Internal audits and follow through on close out of any subsequent actions assigned.
  • Process customer regulatory requests
  • Supporting Quality system improvements and regulatory activities concerning the Quality system.

SKILLS AND KNOWLEDGE:

  • Ability to communicate and work with people inside and outside the department.
  • Ability to co-ordinate, plan and organise
  • Rigorous attention to detail.
  • Working knowledge of Excel and Word.
  • Experience with USA regulatory requirements would be advantageous.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

  • College graduate with Engineering or science degree or equivalent experience.
  • Experience 2-3 years' experience in a similar regulatory role, quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
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