Regulatory Affairs Executive

12 hours ago

Noida, Uttar Pradesh, India SR Strategy Services Full time ₹ 3,00,000 - ₹ 6,00,000 per year

Regulatory Executive (Medical Devices & IVDs)

Experience:
1–3 years in
regulatory affairs for medical devices and/or IVDs under Indian MDR 2017

Location:
Noida (On-site)

CTC :
INR 3-6 LPA

About SR Strategy Services LLP:

SR Strategy Services LLP is a leading consulting firm specializing in strategic government affairs, regulatory advisory, market access solutions, and business transformation. We work with top-tier clients in pharmaceuticals, medical devices, diagnostics, and technology sectors to navigate complex regulatory and policy landscapes in India.

Role Overview:

With a growing portfolio of engagements in medical devices and in-vitro diagnostics (IVDs), SRSS is expanding its Regulatory Affairs team. We are looking for a Regulatory Executive to support multiple client projects simultaneously, covering regulatory submissions, compliance, and interactions with authorities under the Indian Medical Device Rules (MDR), 2017.

The Regulatory Executive will be responsible for supporting end-to-end regulatory activities across a diverse set of medical devices and IVD projects. The role involves preparing and assisting with submissions, advocacy with CDSCO, State Licensing Authorities, related departments and institutions and ensuring compliance with MDR 2017 requirements, while coordinating with client teams and internal stakeholders.

Responsibilities

  • Prepare, compile, and assist in submission of regulatory applications/dossiers for medical devices and IVDs under MDR 2017.
  • Support licensing/registration processes (Forms MD-5, MD-14, MD-15, MD-16, MD-24, etc.) for multiple products and clients.
  • Liaise with CDSCO, State Licensing Authorities, and notified bodies during submission and approval processes.
  • Track and manage multiple regulatory projects simultaneously, ensuring adherence to timelines.
  • Maintain regulatory documentation, trackers, and compliance records for all client projects.
  • Coordinate with SRSS internal teams and client stakeholders to collect required technical and compliance documentation.
  • Monitor regulatory amendments, CDSCO notices, and guidance impacting medical devices and IVDs.
  • Support post-approval activities including license renewals, variations, and responding to authority queries.
  • Assist in audits, inspections, and compliance checks with regulatory authorities as required.

Qualifications

  • Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or related discipline.
  • 1–3 years of experience in regulatory affairs for medical devices and/or IVDs under Indian MDR 2017
  • Familiarity with CDSCO online portal (MD Online System), device/IVD classification, and submission formats.
  • Understanding of ISO 13485 and Quality Management Systems preferred.
  • Strong organizational skills to manage
    multiple projects concurrently
    .
  • Excellent written and verbal communication skills.
  • Proficiency in MS Office Suite.

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