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Regulatory Affairs Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Wexford
  • Sector: Science
  • Date posted: 12/01/2018
  • Job reference: J370715A

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In this role, 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:

o FDA Quality System Regulation 21 CFR 820 (QSR)

o Medical Device Directive

o HealthCanadaMedical Device Regulations

o ISO13485 Medical Device Quality Management System

o ISO14971

o Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related - standard

Assistance with regulatory submissions for:

o CE registration

o 510(k) registration

o Annual reports,

o Supplements and registrations.

Assist with preparation activities for:

o FDA inspections,

o ISO 13485 surveillance audits

o 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.


 - 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.


 - College graduate with Engineering or science degree or equivalent 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

For a more detailed role description or information on other positions, please contact Kathryn on 01-6455244 / 087 3555378

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