Regulatory Affairs Executive / Senior Executive -IVD

Promea Therapeutics; Hyderabad; On-site; INR 600,000 - 800,000; Full time

Job summary

Promea Therapeutics is seeking a Regulatory Affairs professional in Hyderabad to oversee regulatory submissions for IVDs and medical devices. You will manage licenses, approvals, and lifecycle activities, interfacing with CDSCO, DCA and state authorities to ensure timely compliance.

Primary responsibilities include preparing dossiers, handling queries, and coordinating with R&D, QA and manufacturing to maintain regulatory readiness across product portfolios.

Qualifications

• Experience with Class A, B, C, and D IVD product registrations.
• Knowledge of ISO 13485, Quality Management Systems and GDP.
• Experience in regulatory inspections and audits by CDSCO, DCA and others.
• Ability to interact confidently with regulatory authorities and cross-functional stakeholders.

Responsibilities

• Prepare, review, and submit regulatory dossiers for IVDs and Medical Device products to CDSCO zonal office, HQ, and State DCA.
• Manage applications for Test Licenses, manufacturing licenses, product permissions, endorsements, amendments, and renewals under MDR 2017.
• Prepare responses to regulatory queries and deficiency letters.
• Handle regulatory submissions and online portal activities with timely approvals.
• Coordinate with R&D, QA, Manufacturing to compile documentation for regulatory submissions.
• Review Device Master Files of various IVDs and MDs; review labels, IFUs, packaging, and promo materials for compliance.
• Support new product registrations and lifecycle management.

Skills

Regulatory submissions

CDSCO interactions

Post-market regulatory activities

Quality documentation

Regulatory records management

Cross-functional collaboration

Job description

Job Responsibilities

• Prepare, review, and submit regulatory dossiers for IVDs & Medical Device products to CDSCO zonal office and Head Quarters and State DCA, Telangana.
• Manage applications related to Test License, manufacturing licenses, product permissions, endorsements, amendments, and renewals under the Medical Devices Rules (MDR), 2017.
• Prepare responses to regulatory queries and deficiency letters issued by regulatory authorities.
• Handle regulatory submissions and hands‑on experience through the CDSCO and State DCA online portals, and manage all regulatory correspondence to ensure timely submission, effective follow‑up, and receipt of required approvals.
• Coordinate with cross‑functional teams, including R&D, Quality Assurance, Manufacturing, and Production, to collect, compile, prepare, and maintain technical documentation required for regulatory submissions in compliance with applicable regulatory requirements and evaluate regulatory changes and communicate their impact to cross‑functional teams.
• Responsible for preparing and reviewing the Device Master Files of various IVDs & MD.
• Review product labels, Instructions for Use (IFU), package inserts, and promotional materials for regulatory compliance.
• Support new product registrations and lifecycle management activities.

Qualifications and Experience

• Experience with Class A, B, C, and D IVD product registrations.
• Knowledge of ISO 13485, Quality Management Systems, and Good Documentation Practices (GDP).
• Experience in post‑market regulatory activities and license maintenance.
• Ability to interact confidently with regulatory authorities and cross‑functional stakeholders.
• Maintain regulatory records, licenses, approvals, and submission trackers.
• Assist during regulatory inspections and audits by CDSCO, DCA, and other competent authorities.
• Support change control assessments from a regulatory perspective.
• Ensure compliance with applicable Indian regulatory guidelines and standards for IVDs and medical devices.
• Monitor renewal timelines and ensure timely regulatory compliance.