Senior Regulatory Affairs Manager

This is a senior, global regulatory leadership role within Central Function Digital Transformation and Business Enablement (DT&BE) , working with Personal Care, with a strong focus on medical devices in continence care. Based in Gothenburg, you will lead a team of regulatory managers and specialists while acting as the key regulatory business partner for the category. You will operate across the full product lifecycle — from early innovation and regulatory strategy to market maintenance — ensuring compliance with European and US medical device regulations. Working in a complex matrix organization, you will collaborate closely with R&D, Quality, Marketing, and regional regulatory teams to enable compliant, efficient, and business‑focused decision‑making. The position is located in Gothenburg and reports to the Global Regulatory Affairs Director. What You Will Do · Regulatory Leadership: Lead, coach, and develop a team of regulatory managers and specialists in a global, matrix organization · Regulatory Strategy: Define and drive regulatory strategies for medical device products from early development through lifecycle management · Business Partnership: Act as the regulatory business partner for the category, advising stakeholders on regulatory impact, risks, and opportunities · Project Support: Provide regulatory guidance in innovation and change projects, ensuring compliant and timely execution · Compliance Management: Ensure products, technical documentation, and labeling remain compliant with evolving global regulations · Stakeholder Collaboration: Coordinate with regional regulatory teams and external stakeholders to enable successful market access · Process Improvement: Drive harmonization of regulatory ways of working and contribute to continuous improvement initiatives Who You Are You are a seasoned regulatory affairs professional with leadership capabilities and a strategic mindset. You bring deep expertise in medical device regulations, thrive in complex global environments, and are able to balance compliance requirements with business needs. With a collaborative and pragmatic approach, you confidently guide teams and stakeholders through regulatory challenges while driving high-quality, timely outcomes. You have: · A university degree in a scientific or technical discipline relevant to regulatory affairs · Solid experience in regulatory affairs for medical devices, with strong knowledge of European and US regulations · Proven ability to work effectively in global, matrix‑driven organizations and manage complex regulatory topics · A confident communicator with strong project management skills, able to perform under pressure and navigate audits, complaints, and tight timelines · Full professional proficiency in English