Rizwana B
Clinical Evaluation Trainee – Medical Devices (Regulatory Writing: CER/CEP) | PharmD | Former Clinical Research Associate – Drugs (BA/BE, Cosmetics, Clinical Trials, Site Management) | GCP Certified
- Role
- Clinical Evaluation Trainee at Dr.Klinisch Research Pvt Ltd
- Location
- Cuddalore, TN, IN
- LinkedIn followers
- 500 followers
About Rizwana B
As a PharmD graduate with hands-on experience in clinical research, I have developed a…
Experience
Clinical Evaluation Trainee
Jul 2025 — Present · Bengaluru, IN
As a Clinical Evaluation Trainee, I contribute to the preparation of Clinical Evaluation Plans (CEP) and Reports (CER) in compliance with EU MDR 2017/745 and MEDDEV/MDCG guidelines for Class I, IIa, IIb, and medical devices.My responsibilities include: Preparing clinical evaluation checklists and gathering required information from clients. Ensuring CERs meet current regulatory requirements and industry standards. Identifying and describing the state-of-the-art of medical devices. Conducting systematic literature searches and analyzing clinical data to demonstrate device safety, performance, and equivalence. Reviewing adverse event reports and product recalls from global vigilance databases (MAUDE, MHRA, TGA, etc.) for post-market surveillance. Collaborating with cross-functional teams to collect and incorporate supporting documentation.
Education
St.Paul Matriculation Higher Secondary School
10th (SSLC)
2016 — 2017
Sun Institute of Pharmaceutical Education and Research
Doctor of Pharmacy - PharmD, Pharmacology
St.Paul Matriculation Higher Secondary School - Kurinjipadi (tk) Cuddalore (Dt) Tamilnadu.
12th (HSC)
2018 — 2019
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