Main Tasks

• Lead, organise and support key regulatory projects / tasks and regulatory compliance initiatives
• Provide regulatory input to product development projects
• Support preparation of regulatory submissions, license renewals and registrations to international authorities.
• Organise and maintain regulatory documentation to meet regulatory requirements

Requirements

• Higher degree and/or experience 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 of experience with medical devices or regulatory affairs and experience of leading and coordinating projects is strongly preferred
• Experience of regulatory submissions, technical documentation compilation, project management and (EU) 2017/745 Medical Device Regulation is an advantage
• Excellent English (spoken and written) is required, advanced German strongly preferred
• Eager to learn, attention to detail & organizational 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 37,559.20.

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.