Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
Then come and join our global team as Clinical Regulatory Affairs Manager (f/m/d) X-Ray Products to ensure that our products and processes are compliant to global clinical regulatory requirements.
Your tasks and responsibilities:
- You will provide technical advice to internal departments, such as Product Management, Clinical Marketing, with regards to global requirements (laws, guidelines) for clinical evaluations of medical devices with a focus on the European Union, USA and China by:
- Analyzing the global requirements for clinical evaluations, and creating and maintaining work instructions for the implementation of the necessary activities
- Establishing Clinical Lifecycle Management process, especially according to EU MDR. Providing professional advice on establishing claims for medical devices in their clinical environment
- Taking responsibility of some country approval tasks, including regulatory submissions, approval maintenance and development of approval strategy
- Supporting the creation of clinical evaluation reports for EU and China
Your qualifications and experience:
- You hold a university degree in medicine, biology or a comparable field of study, preferably with relevant knowledge of imaging procedures (e.g. radiography, fluoroscopy, mammography) and clinical procedures
- You have long-term professional experience in a clinical regulatory affairs function or in a comparable position in the medical device industry
- You have relevant knowledge and practical experience in clinical lifecycle management as well as clinical evaluations in the European Union, USA and China
- You have good knowledge of regulations and laws on clinical activities, e.g. MDR
- A basic understanding of clinical research methods, including clinical trial/ study design, biostatistics, information management (e.g. using scientific literature databases) and medical writing, is considered a plus
Your attributes and skills:
- You are fluent in English, being fluent in German is considered a plus
- You have the motivation to deliver projects on time and on budget and the ability to manage complex decisions within your team
- You represent high quality standards and are not afraid to implement them together as a team
- On a personal level, your profile is rounded off by decision-making skills, the ability to analyze complex issues and the structured, reliable and goal-oriented handling of tasks
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Check our Careers Site at https://www.siemens-healthineers.com/de/careers
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Wish to find out more before applying? Contact us: +49 (9131) / 17 – 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Marlena Maier.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started.
Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
Organization: Siemens Healthineers
Company: Siemens Healthcare GmbH
Experience Level: Experienced Professional
Job Type: Full-time