Swati A. Bhatawadekar
Medical Writer & Clinical Development Scientist | Clinical Evaluation (CEP/CER, PMCF) | Clinical Evidence | EU MDR/IVDR
- Role
- Clinical Development Scientist Medical Writer at Philips
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Swati A. Bhatawadekar
I am a scientist and medical writer passionate about clinical research and fitness. My aim is to contribute to science and research to bring safe and effective medical devices to patients, and improve their quality of life. • Growth-focused Clinical Scientist with over 10 years of experience leading and managing clinical studies in medical centers • Skilled communicator with a proven ability to communicate scientific ideas effectively demonstrated by 15+ presentations and 8 years of engineering coaching experience • Builder of strong relationships evidenced by collaborations on 10+ clinical projects with scientists and key opinion leaders leading to 15+ scientific publications and 25 abstractsCore competencies- Clinical Evaluation-SaMD- Clinic Development - Medical Device and Drug Regulations- Medical Writing- Clinical Research - Biostatistics and Data analysis - Communication Let’s connect!
Experience
Clinical Development Scientist Medical Writer
Jun 2022 — Present · NJ, US
At Philips, I lead clinical evaluation, clinical development and evidence generation activities for Philips\' software medical devices. Specifically, I prepare clinical evaluation plans and reports, develop post-market clinical follow-up studies, prepare PMCF plans and reports to support product registration and maintenance in the EU and global market.
Education
COEP Technological University
Master's degree, Biomedical Instrumentation
Dalhousie University
Doctor of Philosophy (Ph.D.), Biomedical/Medical Engineering
Cummins College of Engineering for Women, Pune 52
Bachelor’s Degree, Instrumentation Engineering
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