Then come and join our global team as Clinical Regulatory Specialist (f/m/d) and help shape the future of Siemens Healthineers with a strong focus on results, customer needs, and quality.

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.

Even more flexibility? Mobile working from abroad is possible for up to 30 days a year under certain conditions and in selected countries.

Your tasks and responsibilities:

• You advise internal departments such as Clinical Marketing, Product and Project Management on global regulatory requirements for clinical trials, studies, and evaluations of medical devices, with a focus on the EU, USA, and China.
• You support the creation of clinical evaluation reports for submission to regulatory authorities.
• You assist in defining clinical activities related to planned product claims and their substantiation.
• You are responsible for regulatory aspects in the development of clinical strategies as well as in the planning and execution of clinical trials and studies for global approval.
• You analyze international requirements regarding clinical trials/studies/
  evaluations and maintain corresponding work instructions for conducting the necessary clinical activities.
• You coordinate and communicate new or changed clinical requirements to colleagues from various departments involved in clinical trials, studies, and evaluations.
  
  

To find out more about the specific business, have a look at https://www.siemens-healthineers.com/de/products-services    

Your qualifications and experience:

• You hold a degree in human medicine, biology, or a comparable field – ideally with relevant knowledge in imaging techniques (e.g., angiography, CT) and interventional clinical procedures.
• You have many years of professional experience in Clinical Regulatory Affairs or a comparable role in medical technology, clinical research, or contract research.
• You possess in-depth knowledge and practical experience in managing clinical studies and evaluations in the EU, USA, and China.
• You are familiar with clinical research methods, study design, biostatistics, information management (e.g., EDC systems, literature databases), and medical writing.
• You are well-versed in relevant regulatory requirements, especially MEDDEV 2.7/1, ISO 14155, as well as FDA and NMPA regulations.

Your attributes and skills:

• You navigate confidently in our international environment and impress with your strong communication skills; your English is business fluent; German and/or Chinese language skills are a plus.
• You demonstrate a professional demeanor, especially when collaborating with internal departments, international colleagues, notified bodies, and authorities.
• You work in a structured, goal-oriented, and flexible manner – even when requirements change. Quality is your top priority.