My client a leading medical device company is looking to hire a Senior Compliance & Audit Specialist for their Galway site.
My client provides a centralized internal audit services as a core quality service for the CVG network. In this exciting role as a Senior Compliance & Audit Specialist you will have direct responsibility for conducting internal quality system audits and implementing the global Cardiac and Vascular Group (CVG) compliance strategy.
- 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.
Key Skills & Experience
- 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.
- Degree in Science or Engineering
- 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)
- Experience in any of the following key areas: IT (cybersecurity), Manufacturing Operations/ Process Controls, Design and Development and/or Post-Market Surveillance Medical Device Requirements, Pharma/ Combination Device/ Complaints Management.
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