(Senior) Regulatory Affairs Manager (m/f/d) - Clinical Business
Headquartered in Tokyo, Japan, Evident employs around 4,500 people at a total of 57 locations worldwide. Evident Europe, headquartered in Hamburg, Germany, employs approximately 770 people in 16 countries. The product portfolio includes a wide range of microscope systems used in clinical diagnostics, medical and basic research, as well as in various industrial areas. In addition, Evident offers videoscopes, products for non-destructive testing techniques and for X-ray fluorescence analysis.
As a (Senior) Regulatory Affairs Manager (m/f/d) , you will be responsible for strategic and operational regulatory support of digital pathology systems. You will operate at the interface between Regulatory Affairs, Clinical Affairs, Product Development, and Software Development, supporting our products throughout their lifecycle.
Responsibilities
- Develop and implement regulatory strategies for digital pathology products (e.g., microscopes, slide scanners, image analysis software, IMS, viewers).
- Manage and submit national and international regulatory filings (e.g., MDR, IVDR, FDA 510(k), Health Canada, PMDA).
- Prepare and maintain technical documentation in accordance with MDR/IVDR and ISO 13485.
- Support clinical evaluations and develop clinical data strategies in collaboration with Clinical Affairs.
- Support software development projects regarding regulatory requirements (IEC 62304, ISO 14971, SaMD).
- Liaise with external partners, notified bodies, and regulatory authorities.
- Participate in audits, inspections, and regulatory authority interactions.
- Train and advise internal stakeholders on regulatory requirements and developments.
Requirements
- Degree in a scientific, technical, or medical field (e.g., Biology, Medical Engineering, Regulatory Affairs, Medical Informatics).
- At least 5 years of experience in Regulatory Affairs for medical devices, ideally with a focus on digital or imaging systems.
- In-depth knowledge of regulatory requirements in Europe (MDR), USA (FDA), and other relevant markets.
- Experience with Software as a Medical Device (SaMD), IEC 62304, ISO 14971, GxP, and data integrity.
- Understanding of clinical evaluations and studies (e.g., per MDCG guidelines).
- Strong communication and teamwork skills, structured and solution-oriented approach.
- Fluent in English and German (written and spoken).
Benefits
- Flexible working hours, incl. mobile work
- 30 days of holiday per year
- 13,5 salaries a year
- Modern office and inspiring working environment
- Subsidized meals in the neighborhood of our office (Stadtküche)
- Public transport ticket (100% subsidized) or free parking space
- Bike leasing
- Subsidy fitness first gym
- Employee Assistance Program to support your health, mental and emotional well-being
- Comprehensive company pension scheme
- Joint company events and activities
Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.