Arambhi M.
Senior Engineer - RA | Biomedical Engineering | Medical Devices - Quality & Regulatory
- Role
- Senior Engineer - Regulatory Affairs at Tata Elxsi
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Arambhi M.
Worked at Tata Elxsi - With a strong background in biomedical engineering and nearly four years of experience in RA, I used my expertise to navigate and align with EU MDR Requirements and ISO standards, spearheading initiatives to improve product compliance and safety, advancing regulatory compliance for medical devices, and ensuring MDR readiness through detailed gap assessments. The work we\'ve done creating GSPR Checklists and Declarations of Conformity demonstrates our dedication to regulatory excellence. The recognition I\'ve earned through awards such as \'Bravo\' and \'Extra Mile\' illustrates our team\'s commitment to quality and proactive response to regulatory obstacles. My educational experience, combined with certifications in EU regulations, has been crucial in generating novel solutions for the regulatory situation. Preparation for NB filings, diligently attention to detail, and a thorough understanding of regulatory standards remain at the center of our objective to bring compliant medical devices to market. I am continuously looking for new possibilities that match my talents and interest. In addition to my corporate work, I am a freelance content creator helps people improve their personal branding and services. Please feel free to contact me.
Experience
Senior Engineer - Regulatory Affairs
Feb 2023 — Present · Pune, IN
Executed a gap assessment and remediation during the project\'s first stage to make medical devices MDR compliant. • Performing input analysis of respective RA documents in accordance with EU MDR requirements and collaborating with SME to meet the requirements •Involved in the development of Technical Documentation,GSPR Checklist, and Declaration of Conformity (DOC) for various medical devices in accordance with EUMDR requirements. • Preparation of NB Completeness Checklist and NB Submissions.
Education
Bhavan's College
Higher Secondary Certificate (HSC)
Dwarkadas J. Sanghvi College of Engineering
Bachelor of Engineering - BE
Saint Blaise High School
Secondary School Certificate (SSC)
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