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.

Responsibilities

• 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!