Job Type: Sr. Regulatory Affairs Manager
A Berlin based start-up in the innovative medical device industry is seeking for a Sr. Regulatory Affairs Manager to join their team. You can have a positive impact on the lives of millions of people around the globe. You will be one of the early employees, having a major impact, shaping the company through your efforts and industry expertise helping them to certify a medical device to multiple markets this year!
Key Responsibilities of the Sr. Regulatory Affairs Manager:
- Identifying requirements for registrations and approval processes.
- Conducting regulatory approvals for medical devices and ensuring that current regulatory approvals are maintained.
- Processing International approvals for EU and other countries.
- To create and maintain a Quality Management System
- Able to establish and explain in detail how documents are processed.
- Lead Regulatory Projects
Key Requirements of the Sr. Regulatory Affairs Manager Include:
- Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
- 2 + years' experience in Medical device industry.
- Knowledge in marketing surveillance report.
- Experience in writing product description.
- Medical Device Background.
- Experience within Technical Files.
- Background knowledge in MDR Regulations.
- Competitive benefits and great personal development opportunities.
- Great atmosphere within a vibrant team.
- Learning & Development Support both internally and externally
- Flexible working hours
- Great reactions between different teams - Chance to explore other departments
- Flat Hierarchy Structure
- Great progression opportunities
Please Apply online if you are interested in this opportunity.