Senior Regulatory Affairs Manager
Salary/Rate:Circa €80,000 DOE
Job type:Perm
Town/City:Remote
Country:Germany
Business Sectors:Regulatory Affairs
Job ref:25598
Post Date:04. 12. 2024
Scroll
About the Role
Senior Regulatory Affairs Manager (m/f/d)
Location: Germany (Remote)
Overview:
Our client is a registered CRO (clinical research organisation); however, their support and services go beyond those of a typical CRO. The team are specialists in the area of medical device approval and market observation.
Benefits:
Tasks:
Your Profile:
To apply or for more information, please get in touch with Luke Fines by email with a copy of your CV at: luke.fines@adaptivelifescience.com
Location: Germany (Remote)
Overview:
Our client is a registered CRO (clinical research organisation); however, their support and services go beyond those of a typical CRO. The team are specialists in the area of medical device approval and market observation.
Benefits:
- Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work.
- Flexible Work Options: Take advantage of a fully remote, home office position with flexible working hours.
- Generous Vacation Policy: 30-days’ vacation. Recharge and rejuvenate, giving you ample time to relax and enjoy life outside work.
- Permanent Full-Time Position: Permanent employment in a growing company with secure prospects.
- Continuous Evolution & Development: Wide range of development opportunities, including the possibility of team leadership
- Responsible and varied tasks working in a fun and diverse team that works with a diverse range of customers with different challenges and requirements.
- Learning Opportunities; benefit from seminars and other educational opportunities.
Tasks:
- You create and update the technical documentation of medical devices according to Annex II and III of the MDR
- You carry out market surveillance (Post-Market Clinical Follow-up, PMS) in accordance with MDR
- You carry out PMCF activities
Your Profile:
- You have at least four years of professional experience in regulatory affairs for medical devices
- You have a degree in mechanical engineering, electrical engineering or medical engineering or a comparable qualification such as a scientific degree or you have at least 10 years of professional experience in the field of regulatory affairs for medical devices
- You have experience in the approval of medical devices, especially software as a medical device
- You have good knowledge of MDR and FDA requirements as well as quality management
- Good knowledge of IEC 62304
- You are a team player and have strong communication skills
- You are ready to familiarize yourself with new topics and areas
- You have very good German skills (C2 level) and good English skills (at least C1 level)
To apply or for more information, please get in touch with Luke Fines by email with a copy of your CV at: luke.fines@adaptivelifescience.com