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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Regulatory Affairs - Complaints Co-Ordinator


Reference:AMC0010 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs

AMC0010
Regulatory Affairs - Complaint Co-ordinator
6 month contract
Hybrid - Dublin - D12


Product Complaints Coordinator Role


Main tasks:

  • Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company’s Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures.
  • Document and maintain the complaint files for reports received.
  • Prompt communication of complaints received to the Global Complaints Department and escalation of serious product complaint issues, as necessary, to the relevant people both locally and globally, within the required timeframes.
  • Liaise with customers, in collaboration with the Sales teams, regarding product quality issues and also in relation to medical/technical/clinical queries, ensuring an accurate and prompt response.
  • Review product complaint investigation reports and document letters for the customers to relay the investigation results.
  • Contribute to the documentation and review of local procedures for product quality complaints.
  • Attend and partake in internal and external audits related to your job.
  • Support Pharmacovigilance, Medicovigilance and Compliance activities as directed when required.
  • Support the Regulatory team with ad hoc requests and functional requirements.


Qualifications:
  • A degree in a life science or pharmacy discipline.
  • Previous experience of >2 years in the Medical Device /Pharmaceutical Industry and a good understanding and working knowledge of GDP.

Skills:
  • Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland and the EU.
  • Proficiency in the English language; strong verbal and written communication skills is essential.
  • Ability to understand and relay technical information.
  • Accuracy and excellent attention to detail are key attributes along with strong organisational skills.
  • Proven interpersonal skills and the ability to communicate with people at all levels within the organisation and externally.
  • A proactive and collaborative work s and the ability to work with multiple priorities and deadlines.
  • Competent computer skills (Microsoft Word, Excel; SAP an advantage).

If you are interested in this posting please feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information.