Jignesh Desai
Director of Regulatory Affairs SPM AET at Smith & Nephew
- Role
- Director of Regulatory Affairs - Spm Aet at Smith Nephew
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Jignesh Desai
Specialties- Working knowledge of Global Regulatory Submissions for Medical Devices- Understanding of MAA for EU, Latin America, Canada, and Asian Medical Device Regulations- Indepth knowledge of FDA, ICH, ISO 9001, ISO 13485, Quality Standards, Quality Management System and GHTF guidelines- Through Understanding of Premarket approval, PMA supplements, 510(k), STED, and HDE for Medical devices- Well versed with IND, NDA/ANDA, NDA application for Drugs and BLA application for Biologics- Knowledge of Post approval requirements, Annual reports etc for Drugs, Biologics and Medical Devices
Experience
Director of Regulatory Affairs - Spm Aet
Jun 2024 — Present · Andover, MA, US
Education
Bharati Vidyapeeth College of Pharmacy
Bachelor, Bachelor of Pharmacy
2006 — 2010
Northeastern University College of Professional Studies
Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices
2010 — 2012
Skills
- 510 K
- Gdufa
- Glp
- Informed Consent
- Annual Reports
- Pdufa
- Iso 13485
- Nda
- Medical Devices
- Cfg
- Gmp
- Pma
- Supplements
- Anda
- Bla
- Ind
- Snda
- Iso 14001
- Crf
- Mdufa
- Pma Supplements
- Gcp
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