Regulatory Affairs Professional
- İstanbul
- Kontrat
- Tam zamanlı
- Plan and manage the regulatory affairs activities for Turkey organization.
- Prepare product related submissions according to regulatory requirements and submit required documentation/information to local authorities
- Archive the electronic and hard copy documentation on time and properly.
- Update and maintain the product registration database (UTS)
- Coordinate the post market activities including the implementation of FSCAs and Field Actions including translations, notification to Authorities, timely distribution of customers letters and achievement of the required response rate.
- Ensure compliance with the relevant local and EU directives and related regulations in place.
- Support Business Partners for regulatory affairs related projects/requirements.
- Support and guide the bundle countries for regulatory related tasks.
- Support local Quality Management System related tasks
- Bachelor's degree in Engineering, Business Administration or relevant field
- Min 2 years' experience in Regulatory affairs Medical devices/IVDs.
- High level of initiative and flexibility
- Advanced level of English
- No restrictions for travelling
- Strong communication skills
- Good presentation skills
- Detailed oriented
- Problem solving skills
- Proactive nature
- Eager to learn
- Analytical skills
- Highly organized
Vacancies in Turkey