Regulatory Affairs Manager, Getinge Critical Care

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   

Are you interested in becoming part of an international and market leading medical technology company whose products make a huge difference for patients, healthcare professionals and societies all around the world? Apply to be a member of the Regulatory Affairs and Product Compliance team at Getinge Critical Care. As one of the first companies in Sweden to achieve a MDR certificate for our Class IIb products, we strive to be at the front of regulatory compliance and quality process development. 

This position offers you a great opportunity to work cross-functional, locally, and globally, with a wide variety of stakeholders inside the organization. It is an excellent chance to take part in developing and improving world class med-tech products in a challenging regulatory environment within a global and fast-paced manufacturing organization.  

What you will do 

As a Regulatory Affairs Manager you will be a member of the Regulatory affairs and Product compliance team taking ownership for the regulatory aspects of the product area of Anesthesia, Ventilation, Intra- Aortic Balloon Pump and Perfusion, towards internal and external stakeholders. The regulatory team strive for excellence in the regulatory process by taking a leading role in international standardization and development of Getinge global processes.  

Your main responsibilities will include:  

• Establish and maintain documentation for CE-marking according to MDR, i.e. Technical Documentation and Declaration of Conformity 
• Submit and support regulatory applications for China and US, for market clearance/approval 
• Support the R&D throughout the product development process 
  e.g. issue Quality Management Plans, participate in Risk Management and perform document review  
• Support Post market surveillance activities including risk analysis, field actions, Periodic Safety Update Reports and communicating with authorities. 
• Take the lead or participate in cross-functional and global projects such as development of global Getinge procedures. 
• Within your area of expertise support the organization in topics related to standards and standardization and continuously improve our processes 

This position is based in Solna but requires daily global interactions.  

You will bring 

For this position, you have experience within QA/RA and/or R&D from the medical device industry. Experience from regulations and standards, such as QSR, MDD/MDR, ISO13485 and IEC60601, is expected. You have a Master’s degree or corresponding education, in a relevant field together with fluent proficiency in English (our corporate language), and preferably Swedish.  

We also believe that you, in addition, have worked in or with several areas of electrical medical devices, such as development, production, product management, customer support and complaints. 

We highly value your personal skills. We expect you to promote and develop a team player mindset with collaboration both internationally and cross function. As a person you are accurate, action-orientated, driven, communicative and independent with a great amount of integrity.  

You have a coherent, challenging and process-oriented attitude and an excellent ability to communicate and with both internal and external stakeholders. An ability to work in a changing environment is also a key factor for this position. 

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. 

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 2025-06-20  

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 Hiring Manager Jerker Åberg at jerker.aberg@getinge.com or Talent Partner Emma Paulsson at emma.paulsson@getinge.com. 

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.  

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