Regulatory Affairs Specialist
Our client, a medical device company in Offaly are currently looking to recruit a Regulatory Affairs Specialist for their site on a contract basis.
- You will be responsible for ensuring that the company 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.
- 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.
- Candidates must be a good communicator and are fluent in English, both in writing and speaking.
- Candidates should also possess well 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.
- Leadership Expectations provide the framework for what we expect from all employees at our company - outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
For further information on this Regulatory Affairs Specialist role in Offaly please contact Bimi Felix on 0868395533 / firstname.lastname@example.org
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