Clinical Regulatory Specialist (f/m/d)

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.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?

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.