Main Tasks

• Lead, organize and support submissions to Notified Body
• Support preparation of regulatory submissions, licence renewals and registrations to international authorities
• Organize and maintain regulatory documentation and data files to meet regulatory requirements
• Provide regulatory input to product development, product changes and manufacturing changes

Requirements

• Master’s degree is required, preferably in a legal, science or engineering discipline, with a health science or biomedical component e.g. HTA, public health, clinical research, regulatory affairs
• At least 2 years medical device or regulatory affairs work experience is strongly preferred, graduates with any biomedical related experience e.g. in pharma industries, clinical research or health technology assessment are also welcome
• Excellent English (spoken and written) is required, German native speaker or excellent German
• Eager to learn, attention to detail, proven problem solving & organizing skills as well as a collaborative personality

Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is EUR 36,154.72

We offer a challenging opportunity in a multinational work environment with English as our company language. We look forward to receiving your application at jobs.medel.com