In partnership with their client, Head Hunt International Recruitment are currently recruiting for a Regulatory Affairs Specialist role to join a global leader in medical technology in Galway City, Ireland. This is an exciting opportunity to join a company that values what makes you unique. Be part of a company that thinks differently to solve problems, make progress and delivers meaningful innovations. Come for a job, stay for a career!
A DAY IN THE LIFE OF:
* You will be responsible for ensuring that company meets its 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 the resolution of queries related to vigilance reporting, User Reports or requests from Competent Authorities.
* Cultivate an expertise in company's 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.
KEY SKILLS & EXPERIENCE
* 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, instills operational excellence, drive accountability and model ethical behavior
* 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.
REMUNERATION: Excellent Salary/Benefits Package on offer.
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland