Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to ForeverCaring as a Senior Regulatory Affairs Specialist, and you’ll do the same. The Senior Regulatory Affairs Specialist will support the Global business concerning pre and post market matters and ensure success of the business through completing assigned tasks with minimal supervision for change control activities, product promotional activities, labeling review activities, product registration and listing database experience, global product registrations requests, export/import activities, and post market actions and associated activities. Key Responsibilities • Act as RA lead for products under development, liaising with Project Development teams, Project managers including but not limited to R&D, Marketing and Sales and Operations and other QARAC associates. This is to ensure all RA requirements are included in the project plan. Ensure timescales and regulatory pathways are fully understood and baked into the project plan and will be completed. Prepare the pre-marketing documentation for all regions as designated e.g., for CE marking and 510k according to the agreed timeline. • Prepare regulatory strategies and update Technical Files to MDR requirements and engage with global markets to ensure global regulatory compliance. • Maintain regulatory compliance for a range of Infusion Care Devices via change assessment and management of associated regulatory documentation (eg. Technical file updates, letter to file). • Maintain renewals and the up to date information for all appropriate registration and listings databases, supporting global regulatory teams. • Complete regional RA requests and provide the requested regulatory documents. • Review, assess and approve change control requests which affect the marketing of medical devices. • Review and approve labeling change requests, advertising and promotional request, field communications, etc. in accordance with CVT standards and procedures and industry guidances. • Keep informed about new and revised regulatory requirements. • Support as requested by supervisor with all other request for information and documentation associated with regulatory laws and regulations. • Complete all training as required and maintain training plans, records, etc. • Maintain the organization and the security for all regulatory paper and electronic files. • Develop, write, implement and maintain RA procedures. Skills & Experience • Minimum of at least 5 years of experience in medical device Regulatory Affairs is required. • Understanding of the regulatory framework for medical devices. • Experience with Class I, II, III, sterile medical devices. • Familiarity with Class III and active medical devices highly desirable. • Experience in developing and implementing regulatory strategies for New Product Development projects is desirable • Understanding of the Quality System Regulations ISO 13485:2016including preparation and implementation of standard operating procedures • Preferred - experience dealing directly with Notified Bodies, Competent Authorities, and US FDA • Experience with electronic submission is preferred • Experience with US/EU submissions. • International Regulatory Affairs experience is desirable. • Self-starter with the ability to work independently. • Good time management and problem-solving skills. • Strong interpersonal and collaborative skills. • Ability to execute both reactively and proactively and in a timely manner. • Ability to conduct thorough research of regulatory requirements and related issues to identify potential solutions and available options. • Ability to plan, manage and execute project-based tasks often with tight deadlines • Strong analytical skills with good judgment making capabilities. • Demonstrated organizational skills. • Strong oral and written communication skills. • Proficiency with Microsoft Office (Excel, Word, PowerPoint), Adobe Acrobat and Internet-based regulatory resources, Track wise, Documentum etc. Education/ Qualifications • A minimum of a bachelor’s degree in Science, Engineering, Medical Technology or Nurse required. • An advanced degree and/or Regulatory Affairs Certification (RAC) is preferred. Travel Requirements • There may be some business-related travel associated with this role dependent on project and / or local market • Attendance of relevant training and development events would be required. • Some destinations may involve overnight or longer stay(s). Working Conditions • Hybrid working model