Regulatory Compliance Specialist

1 week ago


Galway, Galway, Ireland HERO Recruitment Full time

Company Overview:

Our client is a leading global healthcare company that aims to improve people's lives through innovative technologies.

Job Description:

We are seeking a highly skilled Regulatory Affairs Specialist to support the administration and development of EU Authorised Representative (AR) and UK Responsible Person (RP) activities within the Diagnostics division.

As a key member of our team, you will assist the nominated Person Responsible for Regulatory Compliance (PRRC) in ensuring compliance with established procedures and processes.

You will be responsible for supporting the assessment of the regulatory status of products, preparing for quality audits, and updating company and external databases with required information.

The ideal candidate will possess excellent administrative, organisational, and business support skills, with the ability to multi-task and work calmly under pressure.

Key Responsibilities:

  • Support the administration and development of AR and RP activities
  • Assist in the assessment of the regulatory status of products
  • Prepare for and assist with quality audits
  • Update company and external databases with required information

Required Skills and Qualifications:

  • Familiarity with EU MDR / IVDR and UK and Switzerland MD and IVD regulations
  • Excellent administrative, organisational, and business support skills
  • Ability to multi-task and work calmly under pressure

Benefits:

  • A competitive salary and benefits package
  • Opportunities for professional growth and development


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