Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Officer based on the Coleraine site is responsible for supporting the company in the maintenance of the Regulatory Affairs function, achieving compliance with changing regulations and standards, and meeting company goals and targets by providing a high level of administrative support and registration co-ordination.
KEY ACTIVITIES Manage, prepare, and collate required documentation to support submissions for product approvals and maintenance. Compilation of supporting documents for product registrations. Liaise with Commercial Teams to ensure customer requests are met. Collate data relating to device sales and customer complaints in respective territories. Maintaining Medical device Technical Files in line with Notified Body/Approved Body and regulatory requirements. Ensure adequate control of regulatory documentation and procedures are maintained. Gather and trend Post Market Surveillance (PMS) Data. Liaise with device users, customers, distributors, and importers as needed. Administration of Field Safety Corrective actions. Liaise with device users to obtain further information in relation to reportable events. Ensure that key information relating to PMS and Vigilance is relayed to the Regulatory Affairs Specialist as appropriate. Support review of clinical data and real-world data for compilation within Clinical Evaluation Reports. Perform risk assessments on importers and distributors and ensure appropriate agreements are in place and kept up to date. Supporting the Regulatory Affairs Manager in achieving and maintaining compliance with EU MDD, MDR, REACH, WEEE, US FDA and other regulatory requirements in countries where our products are used. Support regulatory administrative activities within new product development projects. Critical Success Factors Providing administrative support during external and unannounced audits. Responding to internal requests for technical and/or regulatory information. Monitoring changes to regulatory legislation affecting the company. Liaise effectively with other departmental staff. Ensure that confidential company information is protected. Other To adhere to the company's Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible. To be responsible for your own health and safety and that of your colleagues, in accordance with the company's Health and Safety policy. To adhere to the company's Quality policy and Environmental policy. To undertake other duties as may be reasonably required. KEY SKILLS Relevant experience in a manufacturing environment. Educated to GSCEs level or equivalent. Proven experience with Microsoft office suite. Relevant experience in a similar role. Previous experience conducting risk assessments. Degree educated in Law, Business or Science. Knowledge of MDD, EU MDR, UK MDR, ISO13485 and/or MDSAP. Previous experience of electromechanical devices. KEY WORKING RELATIONSHIPS Internal Group Operations. Group Commercial. External Regulatory authorities. Customers, Distributor, Importers and Authorised Representatives. Notified bodies and Approved bodies. ADDITIONAL INFORMATION Ability/willingness to develop within the role. Ability/willingness to attend training courses in relation to the role and the needs of the department. Ability/willingness to travel to other Eakin Group sites as needed. COMPETENCIES Customer Focus: Building strong customer relationships and delivering customer-centric solutions. Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm. Optimizes Work Processes: Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement. Builds Networks: Effectively building formal and informal relationship networks inside and outside the organization. Communicates Effectively: Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences. Instils Trust: Gaining the confidence and trust of others through honesty, integrity and authenticity. Self-Development: Actively seeking new ways to grow and be challenged using both formal and informal development channels. Situational Adaptability: Adapting approach and demeanour in real time to match the shifting demands of different situations. #J-18808-Ljbffr