Regulatory Affairs Executive / Senior Executive -IVD

Promea Therapeutics Pvt. Ltd.; Hyderabad; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Promea Therapeutics Pvt. Ltd. is seeking a Regulatory Affairs Executive/Senior Executive for IVDs and Medical Devices.

You will prepare and submit regulatory dossiers to CDSCO, state authorities, and DCA, and manage licenses and renewals under MDR 2017. You will coordinate with R&D, QA, and manufacturing to compile required technical documentation. Key duties include handling inquiries, ensuring compliance with ISO 13485 and GDP, maintaining device master files, and supporting inspections by

Qualifications

• Experience with Class A, B, C, and D IVD registrations.
• Knowledge of ISO 13485 and GDP.
• Experience in post-market regulatory activities and license maintenance.
• Ability to interact confidently with regulatory authorities and cross-functional teams.

Responsibilities

• Prepare, review, and submit regulatory dossiers for IVDs & Medical Devices to CDSCO, Head Quarters, and State DCA.
• Manage applications for test licenses, manufacturing licenses, product permissions, endorsements, amendments, and renewals under MDR 2017.
• Coordinate with R&D, QA, Manufacturing to assemble technical documentation for submissions.
• Review labels, IFU, and packaging for regulatory compliance.
• Assist during regulatory inspections and audits by CDSCO, DCA, and other authorities.

Skills

Regulatory affairs

Dossier preparation

Regulatory submissions

Cross-functional collaboration

Inspection readiness

Education

Bachelor's degree in life sciences/pharma

Tools

CDSCO portal

State DCA portal

GDP knowledge

Job description

Regulatory Affairs Executive / Senior Executive -IVD

Job ID - 1085

• 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.
• 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.