Role Overview
India Health Link Private Limited is seeking a Regulatory Affairs & Compliance Executive to support Indian and international regulatory activities for medical devices and healthcare products. The role will focus on CDSCO submissions, export regulatory coordination, early-stage US FDA strategy support, quality system documentation, and regulatory compliance across the product lifecycle.
This position is ideal for a hands-on regulatory professional who is comfortable working across teams, managing documentation, and coordinating with external consultants and regulators.
Key Responsibilities
Indian Regulatory Affairs (CDSCO)
Prepare, submit, and track CDSCO applications including Test Licenses, Manufacturing Licenses, and Free Sale Certificates (FSCs) through NSWS and SUGAM portals.
Coordinate clinical study, testing, and evaluation requirements associated with regulatory submissions, working with clinical sites, CROs, manufacturing teams, and internal stakeholders.
Track application status, respond to regulatory queries, and support timely approvals.
International Regulatory Affairs (Export Markets)
Support regulatory pathways for international/export markets in coordination with third-party regulatory agencies and consultants.
Track country-specific regulatory dependencies, documentation requirements, and submission timelines.
Maintain readiness and version control of documentation required for international regulatory submissions and renewals.
US FDA Regulatory Support
Support development and execution of a phased US FDA market-entry strategy, including identification of 510(k)-exempt product capabilities.
Coordinate with CROs and regulatory consultants to assess FDA regulatory pathways, timelines, and scope of work.
Assist in preparing for FDA Quality System and factory-readiness expectations as product scope and risk classification expand.
Quality System & Compliance
Work closely with Quality Assurance teams to maintain ISO-compliant documentation, including Product Master Files (PMF), Quality Manual, regulatory SOPs, and technical documentation.
Draft, review, and maintain regulatory reporting, vigilance, and post-market surveillance (PMS) documentation.
Support internal and external audits related to regulatory, quality, and compliance requirements.
Data Privacy & Other Regulatory Compliance
Coordinate implementation of data-privacy and data-compliance initiatives (including DPDPA requirements) in collaboration with internal teams and external vendors.
Support compliance with applicable pricing, data protection, and regulatory frameworks (e.g., NPPA, DPDPA, where applicable).
Regulatory Strategy & Documentation Management
Maintain device capability matrices, product classification mappings, and intended-use documentation across markets.
Interpret regulatory requirements (CDSCO, US FDA, ISO, NPPA, DPDPA) and identify documentation gaps and mitigation actions.
Act as a regulatory coordination point between manufacturing, QA, clinical partners, consultants, and management.
Qualifications & Experience
Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or a related discipline.
2–5 years of experience in regulatory affairs, quality, or compliance within the medical device / healthcare / life sciences sector.
Hands-on experience with CDSCO submissions and familiarity with NSWS/SUGAM portals.
Working knowledge of ISO 13485, basic FDA regulatory concepts, and international regulatory frameworks.
Strong documentation, coordination, and communication skills.
