Roshini.B
About Candidate
I completed my bachelor’s in biomedical engineering and am pursuing my internship in the medical device industry. I have always been fascinated by the world of pharmaceuticals and the impact they have on people’s lives. I also completed online courses in Pharmacovigilance and Process analytical technology in the pharma industry.
Growing up, I was always intrigued by the idea of creating solutions for health problems, which led me to a career in the pharmaceutical industry, specifically in regulatory compliance. I am also experienced in working closely with R&D and Quality Assurance teams.
This cross-functional experience allows me to understand the impact of regulatory compliance at every stage of a product’s lifecycle and to create effective strategies accordingly.
Location
Education
Work & Experience
In my prior work, I was in charge of advising project teams on how to comply with FDA regulations and recommendations. Responsible for preparation, review and maintenance of quality documents as per ISO 13485:2016 Knowledge on ISO 13485 for design and development of medical products along with IEC 60601 standards Risk analysis in accordance with EN ISO 14971-2012 and revising the risk management file with appropriate mitigation Involved in product classification and risk assessment of the products in development (EU MDR)
