Regulatory Affairs Senior Executive

1. To handle US FDA applications for medical devices registration.
2. To communicate with the Medical Device Authority (MDA) and relevant medical device regulatory bodies (EU and US FDA) or authority bodies (national/international) on product registration and approval such as product CE marking, MDR 2017/745 and US FDA compliance requirements.
3. Accompanying development projects, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentations
4. Examining the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
5. Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of medical devices
6. Realising staff training on the topic of regulatory affairs
7. Staying informed about any changes in legislation (national/international) etc.