Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring and you will do the same. Job Summary: The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting regulatory strategy and registration across global markets across the entire Regulatory Affairs group. Individuals will be expected to help drive regulatory processes and activities (such as regulatory intelligence, global registrations, review of marketing materials, etc.) and continue to develop strong working relationships within RA group as well as internal/external customers. Regulatory Affairs Specialist work includes: • Direct submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports; • Provide strategic product direction to teams on interaction and negotiating evidence with regulatory agencies; • Interact and negotiate with regulatory agency personnel to expedite approval of pending registration and answer questions; • Serve as regulatory liaison on project team throughout the product lifecycle; • Participate in one or all of following activities: product plan development, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC); • Ensure pre-clinical and clinical trial designs meet regulatory requirements; • Ensure rapid, timely approval of new drugs, biologics/biotechnology and/or medical devices, and continued approved drugs/medical devices status; • Serve as regulatory representative to Marketing or Research Project teams and government regulatory agencies; • Advise Development and/or Marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations; • Coordinate, review and prepare reports for submission; coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices. Travel Requirements: Occasional business-related travel may be necessary based on project. - Travel to UK may is possible; some team members are home based and face-to-face contact with Management or team may be required. - Completion and attendance of relevant training and development events would be required. Some destinations may involve overnight stay(s). About You Preferred Education Achievement: Life Science Degree or equivalent. RAPS Certification preferred. Regulatory/Quality experience in medical devices. Experience dealing directly with Notified Bodies and global regulatory authorities. Preparation and submission of regional technical documentation supporting global registrations across multiple territories globally. Continuous improvement mindset with track record of implementing process improvements for regulatory affairs systems. Experience of regulatory requirements for medical devices containing animal derived materials preferred. Experience of regulatory requirements for medical Devices with an Ancillary medicinal substance preferred. Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971. Working Conditions This position is hybrid with a minimum expectation to travel to the office in Lexington 1-2 days every week. Why Convatec? Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone. This is work that’ll move you. #LI-Hybrid Beware of scams online or from individuals claiming to represent Convatec A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com. Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Already a Convatec employee? If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you! Convatec is changing. We’re transforming our business, fueled by a fierce determination to improve the lives of millions more customers around the world. Our shared focus, and the sheer drive of our people, are giving us real momentum. They’re also making us a uniquely invigorating place to work. Join us and, whatever your role, you’ll be pushed and challenged every day. You’ll be supported too, empowered to spark and drive change where it matters most. We have a uniquely dynamic, sometimes demanding environment. But if you’re motivated, and as focused on delivering for patients as we are, it’ll bring the very best out in you. You’ll never stand still. And you might just make the biggest impact of your entire career. If you would like to know how we intend to use your data following your application please refer to our full data privacy policy on the following link: https://www.convatecgroup.com/privacy-policy/