Quality Manager and EU RP

Posted 28 June 2024
Job type Permanent
Contact NameAnita Osibuamhe

Job description

Quality Manager & EU Responsible Person

BioTalent have partnered up with a leading provider of healthcare products and services. Our client has a global presence, operating in over 30 countries across North America, Europe, Asia-Pacific, Latin America, and other regions.


  • Act as EU RP and uphold the WDA license in Dublin.
  • Act as the key contact with HPRA to manage licensed requirements in line with Irish legislation and guidance.
  • Manage the Quality Management System to ensure processes are efficient and in compliance with applicable regulations.
  • Manage the internal audit/self-assessment program.
  • Manage the Risk Management process.
  • Manage adverse events, recalls, field safety communications, and complaints.
  • Conduct, host and coordinate inspections of the organization and its suppliers.
  • Ensure that the organization’s regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations and standards.

Skills and Qualifications

  • Bachelor's degree in Life Science, Regulatory Affairs or related discipline.
  • 5 years' relevant experience within pharmaceuticals or medical devices.
  • Experience acting as EU RP within a pharmaceutical or medical device organisation.
  • QMS experience to the relevant ISO standards: 9001 and 13485.
  • Accredited Auditor Certification is desirable.

Shortlisting for this position has begun with a view to holding interviews over the next week. For further information please contact Anita Osibuamhe at BioTalent on +44 20 3862 2742 for a confidential conversation or apply now!