Reyhan Temizturk
Biomedical Enginner
Ankara
Summary
Seasoned Regulatory Affairs Officer with almost 4 years in developing effective processes and executing regulatory affairs initiatives for medical device industry. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions.
Overview
4
4
years of professional experience
5
5
years of post-secondary education
3
3
Certifications
2
2
Languages
Work History
Regulatory Affairs Specialist
Johnson & Johnson
05.2024 - Current
- Prepared and submitted regulatory file applications and supporting documentation.
- Worked with governance committees to make and evaluate plans.
- Implemented regulatory guidance procedures for CEE Region.
- Streamlined internal processes for timely submission of regulatory documentation to authorities.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Product Submissions for CEE Region
REGULATORY AFFAIRS SPECIALIST
BIOMEDISTA ENGINEERING AND CONSULTING INC.
08.2022 - Current
- Stayed updated on changing regulations by attending industry conferences, maintaining professional expertise in the field.
- Prepared and submitted regulatory file applications and supporting documentation.
- Prepared and maintained document inventory for core dossier preparation.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Maintained and archived regulatory paperwork.
- Supported product development by offering guidance on applicable regulations throughout the process, ensuring adherence at every stage.
- Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
- Monitored post-market surveillance activities, identifying trends and addressing any potential safety concerns promptly.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Streamlined internal processes for timely submission of regulatory documentation to authorities.
INTERN
BIOMEDISTA ENGINEERING AND CONSULTING INC.
01.2021 - 08.2022
- Product and Documents Registration
- Reimbursement of Medical Device
- Actively participated in team meetings, offering insightful suggestions that led to innovative problem-solving strategies.
- Collaborated effectively with team members across departments, fostering a cohesive work environment conducive to accomplishing shared objectives.
- Conducted research for various projects, leading to well-informed decisions and successful outcomes.
Education
Biomedical Engineer -
TOBB UNİVERSITY OF ECONOMICS & TECHNOLOGY
ANKARA, TURKEY 09.2017 - 08.2022
Skills
Innovative
Project Management
Risk Management
Technical Documentation
International Regulations
Medical Device Regulations
Time Management
Certification
Responsible Manager- TCESIS
References
- Prof. Dr. Ahmet Nuri AKAY, TOBB ETU Advisor to the Rector, aakay@etu.edu.tr, +90 532 292 29 29
- Ugur CUNEDİOGLU, President at Biomedical Engineers Association Turkey, +90 530 324 38 23
- Serlin CERAN, Regulatory Affairs Lead-Turkey, Iran& Azerbaijan at Johnson&Johnson, +90 534 889 10 88
Projects
- Development of Mass Sensetive Based Heparin Biosensor Platform by Plasma Polymerization Technique, - Research Project
(The Scientific and Technological Research Council of Turkey 2209-A Research Support)
Timeline
Regulatory Affairs Specialist
Johnson & Johnson
05.2024 - Current
REGULATORY AFFAIRS SPECIALIST
BIOMEDISTA ENGINEERING AND CONSULTING INC.
08.2022 - Current
INTERN
BIOMEDISTA ENGINEERING AND CONSULTING INC.
01.2021 - 08.2022
Biomedical Engineer -
TOBB UNİVERSITY OF ECONOMICS & TECHNOLOGY
09.2017 - 08.2022
Responsible Manager- TCESIS
Sales and Promotion Personne- TCESIS
Clinical Support Staff- TCESIS
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