Our search for better is changing the lives of our customers. It’s changing the careers of our people too – creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to ForeverCaring The role: The Regulatory Affairs Systems Specialist will support database maintenance for Regulatory Intelligence (RIR) and facilitate the Medical/Regulatory/Legal (MRL) and Claims review process. The individual will assist in maintaining process compliance and efficiency, including the initial assessment to ensure the materials submitted are ready to progress, and assigned to the appropriate reviewers. Key Responsibilities: • Support RIR, MRL and Claims processes • Manage reviews and optimal tracking of RIR materials, promotional materials and claims during their life cycle • Follow the MRL and Claims triage process to review material input to ensure appropriate reviewers are assigned and that material can be effectively reviewed. • Interface with cross-functional teams and SMEs to coordinate and assist with the execution of RIR, MRL and claims submissions and reviews. • As required, support the approval of user access requests, to ensure only trained employees can access the electronic workflow systems. • Assist in performing data extraction, analysis to prepare for monthly reports out to leadership. • Assist with preparation of system related presentations and training. • Assist with Standards Review Committee, interfacing with SME’s and Process owners. • Ensure compliance with Company SOPs and WIs. • Ensure all RIR documentation is filed in accordance and in line with Regulatory Intelligence SOP and other applicable Quality SOPs. • Provide feedback and input into new ways of working. Skills & Experience: • Working with MRL review and/or Standard Review committees is strongly preferred. • Demonstrable expertise in Compass or other applicable MRL software strongly preferred. • Proficiency in Microsoft Office applications (Excel, Word, PowerPoint), and Adobe Acrobat. • Familiarity with online based review and/or Regulatory software, is preferred. • Continuous improvement mindset. • Experience with proofreading complex documents. • Experience of working in a regulated industry and quality management. • Demonstrate strong organizational skills, including the ability to prioritize workload • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing, and commercial. Qualifications/Education: • University Degree (or equivalent) Team Part of a small project team. No direct reports. Indirect reports may include project resources. Reporting to Senior Manager – International Regulatory Affairs, additional direction from Global Regulatory Program Director and Sr. Director, Regulatory Affairs Ostomy Care and Continence Care. Principal Contacts & Purpose of Contact Primary contact will be with SME’s associated with RIR, MRL and Claims submissions and reviews, and will include among others R&D, Marketing, Regulatory, Medical, and Legal colleagues across the globe. Travel Requirements Position may involve travel up to 10% of the time, mostly within Europe. Most trips will include overnight travel. Whilst role is remote, regular travel to Convatec Technology Centre Deeside will be required to support face-to-face meetings.