Manager Regulatory Affairs, Getinge Infection Control
Getinge AB (publ)
| Company | Getinge AB (publ) |
| Category | Legal & Compliance |
| Location | SE |
| Remote | Hybrid |
| Employment | Full-time |
| Level | Manager |
| Salary | Not stated by the employer |
| Posted | 29 Jul 2026 |
| Last verified | 9 Aug 2026 |
| Source | Public employment agency (eures) |
Description
Company description: Getinge is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We employ more than 10,000 people, and have operations in more than 40 countries. Saving lives is the greatest job in the world. Everything we do, from architectural planning to the equipment, therapies and solutions aim to secure the safest and most reliable care. As a leading medtech company, we focus every talent and resource towards helping our customers save as many lives as possible. Job description: About this opportunity At Getinge, the Infection Control business area plays a critical role in ensuring that our products meet global regulatory requirements and continue to support healthcare providers in delivering safe and effective patient care. The Regulatory Affairs function works closely with Quality, R&D, Operations, and global stakeholders to ensure compliance throughout the product lifecycle. As RA Manager Infection Control, you will be part of the Quality compliance, Regulatory & Medical organization. You will collaborate extensively across functions and sites within Infection control business area, as well as with global Regulatory Affairs teams and external regulatory bodies. The role offers a unique opportunity to influence regulatory strategy, strengthen cross-site collaboration, and drive regulatory excellence within a highly regulated MedTech environment. In this role, your primary responsibility will be to lead and drive regulatory affairs activities across Infection Control sites, providing strategic direction, ensuring regulatory compliance, and enhancing cross-site collaboration and efficiency. What you will do As RA Manager Infection Control, you will lead regulatory activities supporting both business objectives and compliance requirements. You will act as a key regulatory expert and partner across the organization. Key responsibilities include: Develop and implement regulatory strategies to ensure products comply with applicable regulations and standards. Lead and support regulatory submissions and approvals, including CE marking, 510(k) submissions, and other market authorization activities. Act as the primary contact for notified bodies during technical documentation assessments and regulatory reviews. Review and approve technical files, regulatory documentation, labeling, packaging, and product claims. Drive regulatory intelligence activities, provide training, manage regulatory risks, and support audits, inspections, and non-compliance investigations. The preferred location for this role is Sweden. However, for the right candidate, we are open to a remote and/or hybrid working arrangement. No regular travel is required for this position. You will bring To be successful in this position, we believe you have the following qualifications: Bachelor’s or master’s degree in quality management, Life Science, Industrial Technology, or a related field. At least 3 years of experience in Regulatory Affairs or a related function within a regulated industry. Previous leadership experience (minimum 1 year) with the ability to lead projects and cross-functional teams. Strong knowledge of regulatory compliance, risk assessment, gap analysis, and compliance auditing. Experience working with regulatory databases and advanced Microsoft Office skills. Experience supporting internal and external audits. Meritorious experience includes knowledge of regulatory frameworks and standards such as ISO 13485, ISO 14971, MDR, MDD, MDSAP, and ISO 14001. In addition to your technical expertise, we high