Shubham Pal Email and Phone Number
Working as Sr. QA/RA Executive at Kamal Medtech, a leading manufacturer of medical devices in India. I have 2 year of experience in driving strategies for import and export registration of all classes of medical devices, from Technical Files preparation to submission and query response. I have successfully registered multiple medical devices in overseas countries, complying with the regulations and standards of each market.I hold a M. Pharm degree in Pharmaceutics and Drug Design from Noida Institute of Engineering & Technology, where I learned about the formulation, development, and quality of pharmaceutical products. I also have a B. Pharm degree from SD College of Pharmacy & Vocational Studies, and interned at Swega Laboratories and Swami Kalyandev Govt. Hospital, gaining hands-on experience in various aspects of pharmacy practice. I am passionate about enhancing the quality and safety of medical devices and ensuring their accessibility and affordability for patients. I have developed core competencies in quality system, life science industry, and regulatory filings, and I am eager to learn and grow in this dynamic and challenging field.
Ti Medical
View- Website:
- lotus-surgicals.com
- Employees:
- 366
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Senior Executive Regulatory AffairsTi MedicalGurugram, Hr, In -
Sr. Executive Qa/RaKamal Encon Industries Limited Dec 2023 - PresentHaryana, India1. Conduct Gap Assessment Between MDD vs EU MDR 2017/745 regulations on existing documents like Validation Protocol, Technical Documents and QMS documents. 2. Prepare and Submission of Technical documents as per Indian MDR 2017 for Manufacturing Licence, Test Licence, Import Licence and for Post Approval Change Application to CDSCO Authority. 3. Preparation and Review of process Validation/Revalidation protocol for Cardiac Stent and Drug Eluting Stent medical device. 4. Conduct Internal Audit of as per ISO 134855. Familiar with 5 Why Analysis, 8D, CAPA, Six Sigma, Poka Yoke. -
Regulatory Affairs ExecutiveBl Lifesciences Jul 2022 - Dec 2023Greater Noida1. Responsible for Making Strategies for product Approval in India and for International Countries Registration for APAC, LATAM and EMEA Region. 2. Prepare and Review Technical Documents like Risk Management Report, Risk Management Plan, Clinical Evaluation Report, GSPR, PSUR and SSCP as per EU MDR 2017/745, USFDA. 3. Prepare and Submission of Technical documents as per Indian MDR 2017 for Manufacturing Licence, Test Licence, Import Licence and for Post Approval Change Application to CDSCO Authority4. Responsible for Query response raise by CDSCO Authority and International Regulatory Body. 5. Liasoning with EU REP for procurement of EU FSC for International Registration and preperation of Mandate for CE certificate6. Coordinate with cross functional teams like R&D, QA and QC for the procurement of documents required for submission.7. Responsible for obtaining certificates like Market Standing Certificate, Non Conviction Certificate and Free Sale Certificate from CDSCO for tender Purpose. -
Industrial InternSwega Laboratories Ltd. Jan 2019 - Feb 2019Muzaffarnagar, Uttar Pradesh, IndiaLearn about formulation of Tablet, capsule Ampules, Syrups, Packaging and Quality Assurance
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Pharmacy InternSwami Kalyandev Govt. Hospital May 2018 - Aug 2018Muzaffarnagar, Uttar Pradesh, IndiaLearn and Practice wound dressing, injection, vaccines and stitches in Emergency ward and dispense drugs to patients prescribed by the Doctors
Shubham Pal Education Details
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Pharmaceutics And Drug Design -
Sd College Of Pharmacy And Vocational StudiesB. Pharma -
S.F.D.A.V. Public SchoolP. C. B
Frequently Asked Questions about Shubham Pal
What company does Shubham Pal work for?
Shubham Pal works for Ti Medical
What is Shubham Pal's role at the current company?
Shubham Pal's current role is Senior Executive Regulatory Affairs.
What schools did Shubham Pal attend?
Shubham Pal attended Noida Institute Of Engineering & Technology, Sd College Of Pharmacy And Vocational Studies, S.f.d.a.v. Public School.
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