This is an opportunity to join a global Medical Device company based in Frankfurt who are looking for an Associate Regulatory Affairs Manager to join their team. Due to sustained success, they are expanding their regulatory team, and they are looking for a talented individual to develop their regulatory abilities.
Responsibilities will include:
- Assisting the Senior Regulatory Affairs Specialist with updating and editing EU MDR files for CE marking certification.
- Assist and support regulatory projects, including liaising with multiple different stakeholders including notified bodies.
- Contribute to the development of regulatory strategy.
- Support and review international guidelines and standards, and implement technical documents.
- Academic degree in a Natural Science or Engineering discipline.
- 1-3 years’ experience in Medical Devices, or a Master’s in Regulatory Affairs.
- MDD to MDR transition experience beneficial.
- Understanding of ISO 13485 and ISO 14971.
- Fluency in English, other European languages are a plus.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.