Regulatory Affairs Specialist
Matrix Recruitment
Kildare, Offaly
What you need to know: Interested in working for a highly regarded medical device company as a Regulatory Affairs Specialist? You’ll be based in Tullamore and will be working within a high performing complaint handling and medical device regulatory department. You will be responsible for ensuring the company meets its regulatory obligations and resolving any related enquiries. This is a permanent position that comes with an attractive salary and excellent benefits. Your new job: In this role you will play a key role in the execution of Medical Device Reporting and Vigilance compliance, with a strong focus on complaint handling and regulatory activities. You will be working on a cross functional team with an expectation of working to high standards, driving accountability and meeting strict deadlines. With a big focus on customer service and safety, as well as regulatory affairs, you’ll need to be able to think critically and be a good problem solver. Key duties & responsibilities: Manage the complaint handling system and vigilance related systems. Responsible for the submission of EU Vigilance Reports to external regulatory agencies. Respond to queries from regulatory agencies about complaints and post market regulatory reports. Be an active contributor to continuous improvement and problem-solving initiatives. Provide support to activities related to internal and external audits. Documentation and data interpretation. What are we looking for? Qualified to Leaving Certificate level with any third-level or vocational qualification in a relevant area being advantageous (further training provided on the job. Experience of working in a highly regulated environment, ideally liaising with government or statutory authorities. Understanding of CAPA and complaint handling processes. Strong IT skills are required for MS Office, Corporate Complaint Tracking and Documentation systems Apply for this job now or get in touch with Gareth on 09064 90485. By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and consent. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given. We Value Your Trust. This job originally appeared on RecruitIreland.com.
2080 days ago