Job Detail

Location Clare
Salary Negotiable
Role Type Fixed Term Contract
Contact Marchon Monroe

Regulatory Affairs Specialist

Job ID: JOB-11511
Regulatory Affairs Specialist (ftc)

My client is a pleased to offer a Regulatory Affairs position as their Clare manufacturing site. In this role you will work with the Regulatory and Quality teams to ensure device compliance.

As the RA Specialist, your role covers:

  • RA representative on IDP and Design Change projects.
  • Review & approval of Design verification & validation protocols and reports
  • Development and implementation of registration strategies for new product launches.
  • Support Preparation and submission of 510k for US clearance.
  • Preparation and maintenance of CE technical documentation in compliance with IVDR.
  • Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.
  • Support, where required, in Global RA tasks / projects, which may include supporting RA colleagues outside of the organization.

  • Requirements:
  • B.Sc. Degree qualified
  • 1 + years’ experience in a QA or RA role within a manufacturing facility.
  • It would be a plus if you also possess previous experience in:
  • IVDD Directive, associated harmonised standards and IVD Regulation.
  • ISO13485 and the FDA QSRs.

For further information on this role please contact Marchon Monroe on 086 044 9473/

Check out all our open jobs on our HERO Recruitment website – Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Marchon Monroe


Regulatory Affairs Specialist

Marchon Monroe

Role Type Fixed Term Contract
Contact Marchon Monroe
mobile +353 86 044 94 73
linkedIn profile click here

Senior Controls Systems Engineer


Job ID: JOB-11533 Senior Control Systems Engineer Our client, a leading pharmaceutical company are currently sourcing a Senior Control Systems…


Read More

Packaging Engineer


Job ID: JOB-11520 Packaging Engineer My world leading medical technology client are recruiting for a Packaging Design Engineer for a…


Read More

QP – Qualified Person


Job ID: JOB-11519 My client a leading pharmaceutical manufacturer of both medical and pharma products is recruiting for a QP…


Read More