Reihaneh is highly experienced with worldwide Medical Device regulations for a wide range of products. With her excellent project management and communications skills, she supports the clients through both major projects and their day to day regulatory concerns.
Value to clients
Reihaneh is an expert in all regulatory aspects of Medical Device Regulations throughout the product’s life cycle; from concept and feasibility, through to Technical File and Design Dossier compilation, Post-Market Surveillance and device vigilance.
- Experienced with Medical Devices regulatory affairs for FDA and EMEA (EU, Middle East and Africa) for Class I to III devices
- Knowledgeable in Active Medical Devices and Electrical Safety and EMC regulations
- An expert in Clinical Evaluations for all device classifications, particularly Class III implantable devices
- Commercially aware with great problem-solving skills, always offering the best financially viable solutions to the clients.
Reihaneh has degrees in Medical Engineering and Medical Sciences, majoring in oncology orthopaedic implants. She completed her training as an engineer with Tyco Electronics and moved onto Regulatory Affairs in 2010, first working with Stanmore Implants Worldwide Ltd. Since then she has worked with Hospira where she gained significant experience in product registrations before she took on the Regulatory Affairs Manager role with Olympus KeyMed.
Other things about Reihaneh
- Reihaneh was once guest lecturer, on Medical Device Post-Market Surveillance at University College London
- She is experienced in Quality Management Systems and is a qualified internal auditor
- Reihaneh has significant experience with orthopaedic implants