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India Health Link
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Regulatory Affairs & Compliance Executive

Regulatory Affairs & Compliance Executive

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

India Health Link

2 - 5 years

5 - 9 Lacs

visakhapatnam

Posted:-1 days ago| Platform:

Apply

Skills Required

medical devices manager quality assurance iso 13485 healthcare life sciences regulatory affairs biomedical auditing technical documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

Required Skills

Attention to detail and regulatory risk awareness
Cross-functional coordination
Regulatory documentation & submission management
Audit and inspection readiness support

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Regulatory Affairs & Compliance Executive