<img alt="" src="https://www.getinge.com/siteassets/start/company/careers/Global_careers-portal90127.jpg"> With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. 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: <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Develop and implement regulatory strategies to ensure products comply with applicable regulations and standards. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Lead and support regulatory submissions and approvals, including CE marking, 510(k) submissions, and other market authorization activities. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Act as the primary contact for notified bodies during technical documentation assessments and regulatory reviews. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Review and approve technical files, regulatory documentation, labeling, packaging, and product claims. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Drive regulatory intelligence activities, provide training, manage regulatory risks, and support audits, inspections, and non-compliance investigations. </li> </ul> 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: <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Bachelor’s or master’s degree in quality management, Life Science, Industrial Technology, or a related field. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">At least 3 years of experience in Regulatory Affairs or a related function within a regulated industry. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Previous leadership experience (minimum 1 year) with the ability to lead projects and cross-functional teams. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Strong knowledge of regulatory compliance, risk assessment, gap analysis, and compliance auditing. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Experience working with regulatory databases and advanced Microsoft Office skills. </li> <li style="color:#0f4761;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:115%;font-size:12.0pt;font-family:Aptos, sans-serif">Experience supporting internal and external audits. </li> </ul> 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 highly value your personality. We are looking for someone who combines strong analytical thinking with excellent written communication skills and can translate complex regulatory requirements into clear guidance for non-technical stakeholders. You have the ability to build relationships, influence stakeholders, and lead regulatory initiatives across multiple functions and locations. We believe you have a passion for continuous learning and an eagerness to stay up to date with evolving global regulatory requirements, standards, and best practices within the MedTech industry. At Getinge we see ourselves as proactive and self-driven in learning and contributing to the continued development of our products and our organization's capabilities. We are Team Players, Forward Thinkers and Game Changers. We think you will thrive in a high-expectation environment and have an interest in our products. Why join Getinge Getinge offers a job in a safe and informal work environment, where we appreciate close team collaboration. We keep an open dialogue between leaders and employees, as well as between teams. We are focused on developing people, and together we will create a plan for learning and competence development when you start your career with us. We offer a competitive compensation and benefits package, including wellness allowances, generous family benefits and joint company activities. Everything to ensure we support your well-being and goals. Application Applications will be reviewed continually, and we therefore recommend sending us your application as soon as possible, but no later than 16th August. We kindly ask you to submit your application in our recruitment system by clicking the “apply now” button. Due to GDPR regulations we do not accept applications via e-mail. If you have any questions regarding the role, please contact responsible recruiter Joakim Martinsson at email: <a href="mailto:[email protected]">[email protected]</a> . We look forward to receiving your application. We hope you will join us on our journey to become the world's most desired MedTech company. About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Manager Regulatory Affairs, Getinge Infection Control (Vaxjo, SE) @ Getinge Holding B.V. & Co. KG

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