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Position Name :

Regulatory Affairs CDSCO

Organization :

Corpseed

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences, Biomedical Engineering

Experience:

1 to 2 Years

Salary:

Not disclosed

Location:

Noida

Regulatory Affairs – CDSCO Vacancies in Noida at Corpseed: Apply Now!

Are you a professional in Regulatory Affairs looking to build a career in compliance for medical devices and pharmaceuticals? Corpseed, a leading name in regulatory compliance, is offering exciting opportunities for Regulatory Affairs roles based in Noida, Uttar Pradesh. This role is ideal for those with experience in CDSCO registration, documentation, and regulatory compliance, especially for the medical devices industry.

Job Overview

  • Job Title: Regulatory Affairs – CDSCO
  • Location: Noida, Uttar Pradesh
  • Employment Type: Full-Time
  • Experience Level: Entry to Mid-Level

Key Responsibilities

As a Regulatory Affairs professional at Corpseed, your main responsibilities will include:

  1. CDSCO Registration: Manage registration for medical devices and drugs in compliance with the Central Drugs Standard Control Organization (CDSCO) standards.
  2. Regulatory Submissions: Draft, review, and submit regulatory documents, including query responses, corrections, and post-registration management for the Indian market.
  3. Government Portal Applications: Handle online submissions via Govt. websites for CDSCO and other regulatory bodies.
  4. Medical Device Rules 2017: Ensure compliance with the Medical Device Rules 2017 and ISO standards for medical devices.
  5. BIS, BEE, and FDA Registrations: Familiarity with BIS registration, ISI/FMCS registration, BEE registration, FDA approval, and more.
  6. Technical Documentation: Review and manage technical documents related to CDSCO, Legal Metrology registration, Pollution NOC, and Waste management compliance.
  7. Query Handling: Manage client queries regarding CDSCO registration for medical devices, drugs, and cosmetics.

Qualifications and Skills

  • Education: A degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field.
  • Experience: Experience in regulatory affairs for medical devices or pharmaceuticals.
  • Knowledge: In-depth knowledge of CDSCO regulations, Medical Device Rules 2017, and online submission processes.
  • Skills: Strong documentation skills, experience in filing on CDSCO portals, and handling technical regulatory queries.

How to Apply

Interested candidates are encouraged to send their resumes to nitisha.kumari@corpseed.com with the subject line “Regulatory Affairs – CDSCO Application”. Ensure that your resume highlights your regulatory compliance experience, particularly in relation to CDSCO and medical device rules.

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