Regulatory Affairs Officer

AtEakin Healthcare we put our patient at the heart of everything we do. Fifty years ago, it all started with one mans mission: pharmacist, Tom George Eakin. He saw his patients struggling with leaking urostomy pouches and decided enough was enough. He got to work and formulated what would become the game-changing, eakin Cohesive seal. Fast forward to today, and were still keeping it in the family. Weve grown a lot since then, both organically and through acquisitions. We now have a team of over 700 colleagues across three manufacturing sites and 12 sales and distribution centres. Were making a difference in three therapeutic areas: Ostomy Respiratory Surgical Were proud to export our innovative products to over 60 countries through a network of 40 distributors plus our own offices in Japan, The Netherlands, France, Germany, Belgium and Luxemburg. Were good at what we do come and join us and you can benefit from: Blended Working Bonus 25 days holiday plus bank holidays (rising to 28) Option to buy holiday days Wellbeing Programme Health Cash Plan Pension Life Assurance Enhanced Maternity/Paternity Cycle to Work Scheme Referral Scheme Long Service Awards Free Parking ABOUT THE ROLE 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 companys 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 companys Health and Safety policy To adhere to the companys Quality policy and Environmental policy To undertake other duties as may be reasonably required KEY SKILLS Essential Relevant experience in a manufacturing environment. Educated to GSCEs level or equivalent. Good verbal communication skills. Proven experience with Microsoft office suite. Desirable 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. Skills: Medical Device Regulations Product Registrations Technical Files Post Market Surveillance