Radhika Devi
Senior Medical Device Regulatory Consultant | 14+ Years in FDA 510(k), ISO 13485, EU MDR| Ensuring Compliant Global Launches| Passionate about Patient Safety
- Role
- Product Quality Engineer at Philips
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Radhika Devi
Enthusiastic individual to join hands to protect and improve global human health!Expert in Medical Device Quality Management and Regulatory affairs. Certified Medical Device Professional and Certified Lead Auditor for ISO 13485:2016 Medical Device Quality Management System. Been a visionary in meeting customer and regulatory requirements by enabling the Organization for effective management of Quality Management system. Trained the design engineers on safety standards of Medical Devices and on the importance of regulatory requirements in product life cycle. Proficient in vetting legal documents as per Regulatory needs and supplier certification for authenticity to ensure the Organization\'s steady growth.Thorough knowledge on implementation of ISO 13485:2016 with advance skill set on European regulations and working knowledge on US FDA Quality System regulation. Worked single handled on the Technical file to demonstrate compliance to European directives to obtain CE mark for various medical devices and IVD devices. Facilitated in obtaining certification from Certification body and license from Indian Government. Effective team leader working with cross-functional teams and Original Equipment Manufacturing suppliers for obtaining CE mark under Virtual Manufacturing scheme in close association with notified body reviews. Being a core risk management and FMEA team member from the regulatory affairs to provide safe product to the market. Working as process consultant for various in-house projects to comply with the several International standard requirements.
Experience
Product Quality Engineer
Jan 2025 — Present · Bengaluru, IN
Education
Shanmugha Arts, Science, Technology and Research Academy
B.Tech, Bioengineering
2005 — 2009
ARC Residential School, Mayiladuthurai
Maths, Physics, Chemistry and Biology
2003 — 2005
Amrita Vishwa Vidyapeetham
M.Tech, Biomedical Engineering
2009 — 2011
Skills
- Us Fda 21 Cfr Part 820
- Product Development
- Cell Culture
- Bioinformatics
- Validation
- Life Sciences
- Biotechnology
- Protein Purification
- Pcr
- Fda
- Mdd 93/42/Eec
- Lifesciences
- Quality Management
- Iso 13485
- Windows
- Cell
- Biomedical Engineering
- Medical Devices
- Capa
- Gel Electrophoresis
- Iso 14971
- Elisa
- Quality System
- V&V
- Molecular Biology
- Immunoassays
- Corrective and Preventive Action (Capa)
- Quality Assurance
- Microscopy
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