Bhavik Gondaliya

Bis 2010, Quality Assurance - Jr. Executive, Lyka Labs Ltd.

Winsen (Luhe), Deutschland

Über mich

Master in Pharmaceutics. 12+ Years of Experience in Medical Device and Pharmaceutical Industry in Regulatory, Clinical and Quality area Market Exposure: US, EU, Canada, Australia, Japan, China, Korea, Taiwan, India, Singapore Medical Devices: Class III, High Risk Devices, Drug-Device Combination, Implantable, Biodegradable Products, Companion Diagnostics Cardiovascular and Peripheral Division (Sirolimus Eluting Bioresorbable Vascular Scaffold System, Sirolimus Eluting Coronary Stent system, Cobalt Chromium Coronary Stent System, PTCA Balloon Catheter, PTA Balloon Catheter, Drug Eluting Balloon, Balloon expandable peripheral stent system), Orthopaedic Division (Knee Implant, Hip Implant), Endosurgery Division (Sutures, Intra Uterine Device), IVD (Clinical Biochemistry, Haematology & Coagulation, immunology (ELISA & CLIA), Rapid tests for critical infectious / Vector borne Diseases, Diabetes Management, Blood grouping Sera) Experienced with Injectables Pharmaceutical Dosage Forms

Fähigkeiten und Kenntnisse

Technical Documentation
FDA
ISO 13485
Regulatory Affairs
Medical device
Clinical Research
Medical Device Regulation
Biotechnology and Pharmaceuticals
MDSD

Werdegang

Berufserfahrung von Bhavik Gondaliya

  • Bis heute 5 Jahre und 4 Monate, seit März 2019

    Head of Regulatory Affairs, PRRC

    QualiMed Innovative Medizinprodukte GmbH

  • 1 Jahr und 11 Monate, Apr. 2017 - Feb. 2019

    Regulatory Affairs Manager

    Meril Life Sceinces Private Limited

  • 1 Jahr, Apr. 2016 - März 2017

    Assistant Manager - Regulatory Affairs

    Meril Life Sciences Private Limited

  • 5 Jahre und 3 Monate, Jan. 2011 - März 2016

    Sr. Executive - Regulatory Affairs

    Meril Life Sciences Private Limited

  • 9 Monate, Apr. 2010 - Dez. 2010

    Quality Assurance Officer

    USV Ltd

  • 8 Monate, Aug. 2009 - März 2010

    Quality Assurance - Jr. Executive

    Lyka Labs Ltd.

Ausbildung von Bhavik Gondaliya

  • 2007 - 2009

    Pharmacy

    Rajiv Gandhi Proudyogiki Vishwavidyalaya

  • 2003 - 2007

    Pharmacy

    Saurashtra University

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Grundlagen

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