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Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Contract Type: Permanent
Location: Offaly
REF: 98938
Job Published: about 2 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Regulatory Affairs Specialist

Our client, a medical device company in Co Offaly is currently looking to recruit a Regulatory Affairs Specialist for their site.

At our Post Market Vigilance group, which is part of the Authorised Representative team, we focus on complaint handling and post market regulatory reporting activities for a wide range of products. As a Regulatory Affairs Vigilance Specialist, you will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting (MDR) and Vigilance compliance.
  • You will be responsible for ensuring the client meets is statutory Regulatory obligations under the Medical Device Vigilance requirements of the Medical Device Directive (MDD) within the EEA, and comparable reporting responsibilities in other countries within the EMEA
  • You will be responsible for the timely submission of EU Vigilance Reports to external regulatory agencies in order to maintain regulatory compliance.
  • Ability to liaise and communicate effectively with the business , Regulatory Affairs personnel and other functions as appropriate for resolution of queries related to vigilance reporting, User Reports or requests from Competent Authorities.
  • Cultivate an expertise in the complaint handling system and vigilance related systems in order to perform vigilance tasks effectively.
  • You will also support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports. You will also support both internal and external audit activities.
  • You will contribute to continuous improvement activities and problem-solving initiatives within the department.

  • We are looking for a qualified person to Leaving Certificate or equivalent level. A third-level or vocational qualification in a relevant area would be an advantage. Further training will be provided
  • Applicants should ideally have experience of working within a highly regulated environment (preferably healthcare) and have experience in communicating with government or statutory authorities and should have the ability to generate and review reports on regulatory matters in a timely manner, as well as be accountable for the accuracy and integrity of information provided as input for decision-making.
  • We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams. Experience/understanding of complaint handling or CAPA processes are desirable.
  • Candidates must be able to think critically and make sound decisions. Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour
  • Ability to analyse and interpret data, as required, in order to provide continuous improvement and resolution of issues.
  • Ability to meet strict deadlines and targets to maintain regulatory compliance.
  • Candidates must be a good communicator and are fluent in English, both in writing and speaking. Candidates should also possess good IT and Keyboard Skills and the ability to work with MS Word, MS Access and MS Excel, along with Corporate Complaint-tracking and Documentation Systems
  • Discretion and sensitivity when processing confidential information on patient-outcomes or institutions.

For further information on this Regulatory Affairs Specialist role in Offaly please contact Bimi on 086 8395531 /

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