Shraddha More
Principal Reguatory Affairs at VB Spine
- Role
- Principal Reguatory Affairs at VB Spine
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Shraddha More
A result driven and self-starter Regulatory Affairs professional with 11 plus years of experience in executing regulatory strategies for Class II and Medical Devices in global markets including EU (MDD and MDR), Canada, Asia, Middle East and Russia. Collaborative partner to crossfunctional leads in streamlining processes and boosting results. Focused on executing solutions to complex regulatory complaince projects and providing guidance to budding RA professionals. Education:MS in Regulatory Affairs (cGPA 3.8 /4.0) MS in Pharmacy (cGPA 3.92 / 4.0)Bachelors in Pharmacy (cGPA 3.96 / 4.0)Achievements- Regulatory team lead on executing labeling compliance spanning across several thousand SKUs for an entire division- Mentor to RA professionals on executing complex regulatory strategies and preparing appropriate regulatory submissions- Author of seventeen 510(k) submissions, four MDD, two MDR applications, several Health Canada applications and STEDs in oncology, ocular, gastrointestinal, dental and dural clinical applications - Author of several regulatory assessments for US/OUS custom-made devices and FDA applications for US compassionate use devices in oncology application- Leader in developing successful initial EUMDR QMS audit strategy for custom-made devices, including extension of scope microbiology audits- Regulatory advisor on divesture, merger and acquisition projects - Collaborator with cross-functional teams in developing and executing effective processes that resulted double digit impact
Experience
Principal Reguatory Affairs
Apr 2026 — Present · Allendale, NJ, US
Education
NIPER
Masters, Pharmaceutical Biotechnology
2007 — 2009
University of Southern California
Masters, Regulatory Science
2012 — 2013
NDMVP College of Pharmacy
Bachelors of Pharmacy, Pharmaceutical Sciences
2003 — 2007
Skills
- Iso 13485
- Clinical Trials
- Life Sciences
- Regulatory Affairs
- Lifesciences
- Technology Transfer
- Medical Device Regulations: Class Ii and Class Iii (Hud)
- Pharmaceutical Industry
- Sop
- Fda
- Gmp
- Pma
- Biotechnology
- Regulatory Submissions
- Design Control
- Quality System
- Standard Operating Procedure (Sop)
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