Shubham Pal

Shubham Pal Email and Phone Number

Senior Executive Regulatory Affairs @ TI Medical
Gurugram, HR, IN
Shubham Pal's Location
Faridabad, Haryana, India, India
About Shubham Pal

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.

Shubham Pal's Current Company Details
TI Medical

Ti Medical

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Senior Executive Regulatory Affairs
Gurugram, HR, IN
Employees:
366
Shubham Pal Work Experience Details
  • Ti Medical
    Senior Executive Regulatory Affairs
    Ti Medical
    Gurugram, Hr, In
  • Kamal Encon Industries Limited
    Sr. Executive Qa/Ra
    Kamal Encon Industries Limited Dec 2023 - Present
    Haryana, India
    1. 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.
  • Bl Lifesciences
    Regulatory Affairs Executive
    Bl Lifesciences Jul 2022 - Dec 2023
    Greater Noida
    1. 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.
  • Swega Laboratories Ltd.
    Industrial Intern
    Swega Laboratories Ltd. Jan 2019 - Feb 2019
    Muzaffarnagar, Uttar Pradesh, India
    Learn about formulation of Tablet, capsule Ampules, Syrups, Packaging and Quality Assurance
  • Swami Kalyandev Govt. Hospital
    Pharmacy Intern
    Swami Kalyandev Govt. Hospital May 2018 - Aug 2018
    Muzaffarnagar, Uttar Pradesh, India
    Learn and Practice wound dressing, injection, vaccines and stitches in Emergency ward and dispense drugs to patients prescribed by the Doctors

Shubham Pal Education Details

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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