Regulatory Affairs Project Manager

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Matrix Recruitment are seeking to recruit a Regulatory Affairs Project Manager for our multinational client, based in the Wexford region.

This is a very innovative site where they manufacture a wide array of products & Technology within the life science space.

***This role offers remote working/ with some onsite requirement for business needs***

This is a permanent job with some travel abroad for training…

Key duties & responsibilities:

  • Responsible and accountable for regulatory support
  • Primary focus on UDI, for operations, product development and quality to ensure that the product is in compliance with all regulatory requirements
  • Regulatory Affairs Subject Matter Expert on UDI requirements globally
  • Implement and maintain global UDI requirements and associated procedures for two company sites
  • Train Regulatory Affairs & Quality System team members on UDI processes and systems
  • Assist in the development and improvement of Regulatory processes and procedures
  • Participates in product development/line extension teams as required
What are we looking for?
  • Degree in Science or Engineering
  • Minimum 4 years RA and/or Quality Systems experience
  • Medical Device/Pharmaceutical or Life Science Industry experience
  • Strong regulatory knowledge around guidelines, policies, principles and requirements of applicable product laws/standards
  • Must be able to travel
  • German knowledge an advantage

Apply for this job now by emailing your WORD formatted CV to Patricia.

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    Recruitment Consultant: Patricia Deane

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