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Senior Compliance and Audit Specialist

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Recruiter: Real Staffing
Listed on: Today, 12:03pm
Location: Galway
Type: Permanent
Start Date: ASAP

My client are a world renowned medical device technology leader. They have been present in Ireland since 1999 with multiple sites here. Over 2500 people are employed in Ireland with most of the company's employees working at the facility in Galway. This site is their centre of excellence for the development and manufacture of a number of the company's key medical technologies for the treatment and management of cardiovascular and cardiac rhythm diseases.

They are currently looking for a Senior Compliance and Audit Specialist to join their team.This is a permanent role with great benefits.

What will I be doing as a Senior Compliance and Audit Specialist ?

  • Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
  • Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
  • Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
  • May counsel stakeholders about these requirements as necessary.
  • Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
  • Analyses audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
  • Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

What I need to be a Senior Compliance and Audit Specialist.

  • Bachelor's degree with 4+ years of Quality Management Systems, Regulatory, Compliance and/or Audit experience or Advanced degree with 2 +years of Quality Management Systems, Regulatory, Compliance and/or Audit experience.
  • Desired Quality System Lead Auditor certified
  • Experience with FDA, MDSAP, EUMDR or similar regulated bodies medical device requirements.
  • Experience auditing Quality Systems to global requirements
  • Experience within healthcare industry (e.g. medical device, biotech, pharma)

If you think the position in Galway is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. I will contact you upon application and discuss this further with you! Please note sponsorship is not offered with this role.

To find out more about Real please visit www.realstaffing.com

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

Contact Name: Katie Dunne
Reference: TJ/3386/RE-33372462_1580731425
Job ID: 2791078



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