At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We’ve been recognised as a Great Place to Work® ! And we’re proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women. At Eakin Healthcare, we’re united by one mission: working together to improve lives - just like we’ve been doing for over five decades. WHY JOIN US? We’re 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 Specialist, based from either the Cardiff or Comber site, is responsible for supporting the group in ensuring requirements for medical device regulatory compliance are identified, achieved and maintained. KEY RESPONSIBILITIES Regulatory Compliance Maintain medical device technical files in line with current regulatory requirements. Generate reports relating to device sales, complaints and other post-market data. Analyse and trend Post Market Surveillance (PMS) data; compile and distribute PMS reports. Create and maintain appropriate regulatory documentation on relevant e-QMS and document management systems, as required. Ensure adequate control and maintenance of regulatory documentation and procedures. Ensure regulatory compliance is integrated into New Product Development (NPD) projects and complete assigned regulatory tasks. Implement and maintain changes in regulatory legislation that affect the Quality Management System. Contribute to the continual improvement of regulatory affairs processes and systems. Support the Regulatory team in achieving and maintaining compliance with EU MDD, UK MDR, EU MDR, ISO 13485, MDSAP and other national regulatory requirements in countries where our products are used. Conduct regular risk management activities, including product-related risk assessments, to ensure compliance with ISO 14971 requirements. Assist the Regulatory Affairs Manager during routine and unannounced internal / external audits. Maintain effective communication and relationships with regulatory authorities. Scheduling and monitoring Maintain the Regulatory Schedule in line with Post Market requirements and Periodic review requirements, including but not limited to PMS / PSUR, Clinical Evaluation, Economic Operator Mandates etc. Monitor and evaluate regulatory updates from external sources (e.g. Standards, Common Specifications, MEDDEVs, Industry guidance) and communicate the relevant changes to the team Device registration Maintain annual registrations with Regulatory Authorities such as the US FDA and others as required. Compile plans and reports required to support product approvals submissions. Respond to internal and external requests for technical or regulatory information, including support for device registrations and licencing. Vigilance / Recall Conduct vigilance activities and assist in the reporting and monitoring of adverse events to the appropriate authorities. Prepare and submit adverse incident reports in a timely manner. Execute activities related to Field Safety Corrective Actions, as required. Liaise with business partners, distributors and other entities in relation to vigilance and recall activities. 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 WHAT WE’RE LOOKING FOR Essential Degree educated in science, business, law or proven experience in a similar role Previous experience in a regulatory role Strong administration skills Meticulous with high levels of attention to detail Ability to work under pressure and to tight deadline Effective team player with strong communication skills Proficient in MS office Desirable Experience with ostomy medical devices. Previous experience in medical device Knowledge of EU MDD, EU MDR, UK MDR, ISO13485 and/or MDSAP. Experience carrying out risk KEY WORKING RELATIONSHIPS Internal Operations QARA Teams R&D Commercial Teams External Regulatory authorities Notified Body/Approved Body Customers, Distributor, Importers and Authorised Representatives. Suppliers ADDITIONAL INFORMATION Occasional travel to other Eakin Healthcare sites may be required Ability / willingness to attend training courses in relation to the role and the needs of the department Ability / willingness to develop within the role COMPETENCIES Ensures accountability Holding self and others accountable to meet commitments. Collaborates Building partnerships and working collaboratively with others to meet shared objectives. Manages complexity Making sense of complex, high quality and sometimes contradictory information to effectively solve problems. Decision quality Making good and timely decisions that keep the organization moving forward. Interpersonal savvy Relating openly and comfortably with diverse groups of people. Being resilient Rebounding from setbacks and adversity when facing difficult situations. Situational adaptability Adapting approach and demeanour in real time to match the shifting demands of different situations. Optimizes work processes Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement. SJ