Regulatory Compliance Specialist

6 days ago

Cork, Cork, Ireland beBeeKnowledge Full time €60,000 - €80,000

Job Title: Quality Assurance Associate

Location: Cork, Ireland

Developing a strong working knowledge of medical device regulatory requirements and standard practices in the medical device industry is key to success in this role.

Responsibilities include:

  • Maintaining the effectiveness of the Quality Management System (QMS) by identifying areas for improvement and implementing corrective actions.
  • Managing day-to-day QA activities, including regular communication with contract manufacturers, QA consultants, and testing contractors.
  • Assisting in notified body audits and internal audits to ensure compliance with quality standards.
  • Building and maintaining strong relationships with suppliers, monitoring their performance, and conducting regular audits to ensure compliance with quality standards.
  • Investigating, analysing, and resolving any product quality problems through root cause analysis and implementing corrective and preventive actions.

Requirements:

  • A bachelor's degree in engineering or science is required.
  • Quality certification in ISO 13485 is essential.
  • A minimum of four years of experience in a medical device QA position within a medical device organisation is necessary.
  • Thorough understanding and knowledge of ISO 13485 and ISO 14971, EU MDR, and 21 CFR Part 820 are required.

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