Senior Regulatory Affairs Manager

Responsibilities

• 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

Requirements

• 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

Additional Information

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.

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Company Intel

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