Quality/Regulatory Specialist

Competitive
Permanent
Cork
23 May 2019
BBBH731352

Multinational company looking for a self motivated, autonomous & driven Quality Specialist to join a newly created team

This is an excellent role within a multi-national company where you will have the opportunity to join a newly created team. This opportunity will suit someone who is comfortable working in an ambiguous environment, and who will see the opportunity in the fact that systems and processes are still being established and that they would be in a position to make an impact on those processes.

This role will give the successful individual the opportunity to build and maintain new relationships with customers, regulatory bodies and suppliers.

This role will support the European side of the business and the main duties of the role will focus on preparing the application for CE marking, working closely with the business on customer complaint handling and the individual will help implementing the complaints handling system.

Someone who has strong systems experience and who has experience working with international teams would work well within this environment.

Experience Required:

  • 4 plus years' experience in Quality Assurance and/or regulatory affairs in the Medical Device or Pharmaceutical Industry
  • Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485:2016, ISO 14971 and ISO10993 series)
  • Knowledge of Cosmetics and Food supplement regulation is advantageous.
  • Experience with customer complaint handling

Education:

Degree level in science/engineering.

Specialized Knowledge/Skills:

  • Excellent communication skills with a strong background in Technical Writing
  • High learning aptitude and adaptability with software systems
  • Ability to work in a changing environment and through transition periods
  • Demonstrated efficient work methods, analytical and problem-solving skills and ability to handle multiple tasks in a fast-paced environment
  • Demonstrates understanding of customer needs / requirements, consistent with organization priorities
  • Understanding of customs and beliefs of other groups or cultures

Limited travel, both regional and international will be required as part of this role.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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Kellie O'Donovan's picture
Consultant | Engineering Recruitment - Quality & Validation
Cork 353 (0) 21 2300300 | kodonovan@morganmckinley.ie