Regulatory Affairs Specilaist

Location: Wexford, Republic of Ireland
Salary: No information
Job Type: Permanent
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I'm currently working with a leading medical device company based in Wexford.They are a medical device contract manufacturer. Due to growth, they need an ambitious Regulatory Affairs Specialist to join them.

This is a permanent role with great benefits.

What will I be doing as a regulatory Affairs Specialist?

  • Ensure continuous compliance with
  • FDA Quality System Regulation 21 CFR 820 (QSR)
  • Medical Device Directive & Medical Device Regulation
  • Health Canada Medical Device Regulations
  • ISO13485 Medical Device Quality Management System
  • ISO14971
  • Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
  • All Internal Procedures· Assist with preparation and closing activities associated with:
  • Assist with regulatory requests from customers and notified bodies, technical files etc.:
  • United States FDA inspections
  • ISO 13485 audits
  • Other Regulatory Agency Audits
  • Internal audits
  • Process customer notification and regulatory requests
  • Support Quality system and regulatory system improvements activities
  • Be an active member of the team and work with all associates to develop a world class lean manufacturing system.

What I need to be a Regulatory Affairs Specialist ?

  • Ability to communicate and work with people inside and outside the department.
  • Ability to supervise
  • Ability to co-ordinate, plan and organise Rigorous attention to detail.
  • Excellent attention to detail and organisation skills.
  • Ability to work to deadlines and on own initiative.
  • Excellent interpersonal skills Excellent verbal and written communication skills.
  • Working knowledge of Excel and Word.

If you'd like to discuss the chance of becoming Regulatory Affairs Specialist, please send across your current CV and we can have a confidential conversation about this opportunity.

To find out more about Real please visit

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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