Clinical Regulatory Specialist | Clinical Regulatory Specialist (w/m/d)
Siemens AG
Job Summary
As a Clinical Regulatory Specialist at Siemens Healthineers, you will play a pivotal role in shaping the future of healthcare by providing expert guidance on global regulatory requirements for clinical trials and medical device evaluations. Your day-to-day responsibilities include advising internal departments like Clinical Marketing and Project Management, specifically focusing on markets in the EU, USA, and China. You will oversee the creation of clinical evaluation reports, define clinical activities for product claims, and develop regulatory strategies for international product approvals. This role is highly collaborative, requiring coordination across various specialist departments to ensure compliance with evolving international standards. What makes this position unique is the high degree of flexibility, offering up to 60% mobile work within Germany and the opportunity to work abroad for up to 30 days a year. Joining this global leader allows you to work at the intersection of cutting-edge medical technology and international law, ensuring innovative diagnostic and therapeutic solutions reach patients worldwide.
Required Skills
Education
University degree in Human Medicine, Biology, or a comparable field of study.
Experience
- Extensive professional experience in Clinical Regulatory Affairs or a comparable function within the medical technology or clinical research industry
- Proven track record in managing clinical trials and evaluations specifically for the EU, USA, and China markets
- Practical experience in clinical research methodology, study design, and biostatistics
- Experience in collaborating with international authorities and notified bodies
- Professional background in imaging procedures (e.g., Angiography, CT) or interventional clinical procedures is highly preferred
Languages
Additional
- Mobile work possible up to 60% within Germany; optional international mobile working up to 30 days per year under specific conditions. Knowledge of Chinese is considered an advantage.
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