Rupal Singhal
Regulatory Affairs Associate | Medical Device / Equipment Technical Documentation | Empowering organizations to Regulatory Compliance for their products by meeting specific regulatory requirements
- Role
- Regulatory Affairs Associate at Triage Meditech Pvt Ltd
- Location
- New Delhi, IN
- LinkedIn followers
- 500 followers
About Rupal Singhal
An accountable Medical Device Regulatory Affairs Professional with understanding of both legal and scientific matters. I help organization keep up to date by compliance with applicable national and international standards, guidelines and customer practices. As a RA Professional, I collect, analyze and coordinate information to prepare regulatory documentation and technical dossiers for submission to regulatory agencies • I work by Identifying and interpreting regulations, guidelines, standards and other pertinent information issued by applicable regulatory agencies and other associated regulatory authorities. • Review product requirements, help implement ISO standard (ISO13485) to update Quality System documents and ISO standard (ISO 14971) for risk assessment and management process • Provide input for regulatory requirements and regulatory strategies in cross-functional team on product development to ensure timely submission and approval. • Collaborate with engineers, QC/QA to create quality submissions ensuring successful review by regulatory authorities. I believe persistent Active Learning with adaptability attribute helps in the implications of new information for both current & future problem-solving and decision-making to considerable variety in the workplace.
Experience
Regulatory Affairs Associate
Jul 2022 — Present · New Delhi, IN
As a Regulatory Affairs Associate, I assist Manager QA/RA in upkeep and updation of technical dossier. Providing support for regulatory affairs activities to assist in regulatory submission, registrations, in compliance with applicable medical device regulations per jurisdiction, guidance and standards.\\\\n\\\\n• Compiled Quality documents in a format consistent with applicable guidance documents.\\\\n\\\\n• Added advantage by assuring appropriate maintenance of technical documents as per ISO\\\\nstandards / Regulatory guidelines as applicable.\\\\n\\\\n• Coordinate for regulatory inputs and participate in findings of non-compliance.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Education
Jamia Hamdard
MBA ( Pharmaceutical Management )
2018 — 2020
Amity University, Gautam Budh Nagar
B.pharmacy
2013 — 2017
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