Parth Pathak
Regulatory Affairs Manager
- Role
- Regulatory Affairs Manager at Abbott
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Parth Pathak
Medical Devices & Diagnostics – 510(k), PMA, IDE, CAPA, FMECA, MDUFA, HUD, Design Dossier, CE Technical Files• Drugs and Biologics – Pre-IND, IND, NDA, ANDA and BLA.• Clinical Trials – GCP-ICH Guidelines, Clinical Investigational Plan, Preclinical Testing, IRB, Informed Consent• Quality Systems and Standards – QSR, QMS, ISO standards (13485:2003, Design Controls, Verification and Validation• Global Regulatory skills: European Union, Canada, Australia, Asia and Latin American countries regulations.• Other Skills - Advanced technical writing and public speaking skills, strong computer skills, ability to master new tools quickly, excellent analytical and organizational skills, self-motivated and rich internship experiences.
Experience
Regulatory Affairs Manager
Jul 2023 — Present
Education
University of Mumbai
Bachelors, Pharmacy
2005 — 2009
Nirma university
Bachelors of Pharmacy ( Honors ) Fifth Year, Pharmacy
2010 — 2011
Northeastern University
Masters, Regulatory Affairs for Drugs, Biologics and Medical Devices
2011 — 2012
Skills
- Sop
- Bla
- Design Control
- Cgmp
- Spa
- Pharmacovigilance
- Gmp
- Iso 14971
- Medical Devices
- Clinical Research
- Capa
- Quality System
- Product Labelling Regulations
- Gcp
- Fmea
- Qsr
- Design Dossiers
- Ide
- Glp
- Iso 13485
- Mdr
- Irb
- Hud
- Regulatory Affairs
- Ce Technical Files
- Fda 21 Cfr Regulations
- 510 K
- Anda
- Quality Assurance
- Pma
- Clinical Trials
- Ind
- Class Ii
- Bmr
- Ectd
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