Regulatory Affairs Responsible (Non-Drug Products) – Maternity Cover

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need experts ready to shape what’s next. As a Regulatory Affairs Specialist (Non-Drug Products) , you’ll bring your expertise, curiosity and drive to make health simpler, smarter and more human. About the job This position is a fixed-term maternity cover contract within the Regulatory Affairs team. The Regulatory Affairs Specialist supports regulatory compliance and lifecycle management activities for a portfolio of Medical Devices, Food Supplements and In Vitro Diagnostic Devices (IVDs) . Working closely with Global and Local Regulatory Affairs teams, as well as Quality, Innovation and Supply Chain functions, you will ensure products remain compliant with applicable regulations while supporting business continuity, innovation and market expansion. Main Responsibilities Manage regulatory activities for assigned product portfolios, ensuring compliance with applicable local and global regulations. Prepare and maintain regulatory documentation for Initial registrations, Site registrations, Territory extensions, Variations and changes, Renewals, Responses to Health Authority inquiries. Support product license maintenance and site registration activities. Evaluate the regulatory compliance of new products, including in-licensing and development projects. Assess regulatory impact of product, manufacturing or labeling changes and support change control activities. Coordinate regulatory submissions and interactions with Global Regulatory Affairs (GRA), Local Regulatory Affairs (LRA) teams and external partners. Provide regulatory support to cross-functional teams, including Quality, Innovation, Supply Chain and Transfer projects. Monitor regulatory developments and assess their impact on the product portfolio. Contribute to due diligence activities and regulatory assessment of new business opportunities. Support audits, inspections and quality reviews, as appropriate. Contribute to regulatory KPI tracking and continuous improvement initiatives. About You Experience in Regulatory Affairs within the healthcare industry, preferably in Medical Devices, Food Supplements and/or In Vitro Diagnostic Devices (IVDs) . Good understanding of global regulations and guidelines applicable to non-drug products. Experience working in a regulated environment with strong awareness of compliance requirements. Strong communication and stakeholder management skills, with the ability to work effectively across cross-functional teams. Excellent organizational skills and ability to manage multiple priorities in a dynamic environment. Proactive, solution-oriented and able to work independently. Experience with regulatory submissions, registrations and lifecycle management activities. Knowledge of Veeva Vault RIM or similar regulatory systems is considered an advantage. Degree in Pharmacy, Life Sciences, Chemistry, Biomedical Engineering or a related field. Fluency in English, both written and spoken. Additional languages are considered an asset. Location: Budapest Contract type: Fixed-term contract (Maternity Cover). Hybrid working policy: 2 days remote working/week. This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella. About Us: Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com . #LI-HYBRID