(Senior) Regulatory Affairs Manager (m/f/d) - Clinical Business
(Senior) Regulatory Affairs Manager (m/f/d) - Clinical Business
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Headquartered in Tokyo Japan Evident employs around 4500 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) - Clinical Business 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.
Tasks
- 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 time each year
- 135 salaries a year
- Regular training courses
- Extensive company pension scheme
- Payments towards an employee savings plan
- Preventive healthcare free beverages & fresh fruit and vegetables daily
- Joint company events and activities
- Interesting diversified field of activity in an international working environment
Evident Europe GmbH is an equal opportunities employer and we look forward to receiving your application.
Employment Type
Full Time
