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) to help shaping the future of Siemens Healthineers with your expertise in the Regulatory field.
Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.
Your tasks and responsibilities:
- You will provide professional advice to and actively support internal departments, such as product management, (clinical) marketing- and product development in implementation and fulfillment of global requirements (laws, guidelines) for clinical evaluations of medical devices with a focus on the European Union (EU), China and the USA by
- Analyzing global requirements for clinical evaluations, and creating, shaping and maintaining process framework for the implementation of the necessary activities in the pre- and post-market phases
- Following a Clinical Lifecycle Management approach together with the interfacing departments, to ensure optimal utilization of synergies, operational efficiency and regulatory compliance essential for the EU, Chinese and US markets
- Counselling in clinical evaluation, clinical development, and PMCF strategies for different portfolio segments
- Guiding the clinical claim management process from a regulatory and evidence perspective
- Supporting the creation of clinical evaluation reports for the EU and China ensuring compliance with applicable regulations and timely provision to authorities
- Aligning global clinical evidence strategies for the major markets with the product portfolio strategy and strategic business targets
- Build-up and disseminate required clinical knowledge within the organizations by providing consultations, training, and workshops
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services
Your qualifications and experience:
- You have a university degree in medicine, biology, medical engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures
- You have several years of professional experience in the clinical and regulatory affairs functions or in comparable positions in the medical device industry, and you are very familiar with relevant interfacing processes, such as product risk management, post-market surveillance, and product lifecycle management
- You have experience in scientific research and writing
- You ideally demonstrate functional knowledge of the clinical research methods, including clinical investigation/study design, biostatistics, and information management
- You have throug knowledge of the pertinent regulatory frameworks of the EU, China, and the USA
- You ideally have practical experience in the strategic clinical lifecycle management in a medical device company
Your attributes and skills:
- You show a collaborative, inspiring working stile, and you can accommodate different personalities in a functional team
- You have excellent written and spoken German and English communication skills
- You are a great communicator, collaborative, inspiring, and able to accommodate different personalities in a functional team
- You are experienced in working in a demanding environment, and you pursue the aligned strategic targets by prioritization, consolidation, and smart decision making
- We win together: you are a team player; you follow the Siemens Healthineers goals with dedication and passion for the job
Our global team:
Siemens Healthineers is a leading global medical technology company. 68,000 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.
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
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Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
Organization: Siemens Healthineers
Company: Siemens Healthcare GmbH
Experience Level: Experienced Professional
Full / Part time: Full-time