PPIC - Executive
PROMEA THERAPEUTICS PRIVATE LIMITED
Regulatory Affairs Executive / Senior Executive -IVD
About this role
- 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.
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs Executive / Senior Executive -IVD position at PROMEA THERAPEUTICS PRIVATE LIMITED?
The salary for this Regulatory Affairs Executive / Senior Executive -IVD role at PROMEA THERAPEUTICS PRIVATE LIMITED is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Executive / Senior Executive -IVD position at PROMEA THERAPEUTICS PRIVATE LIMITED located?
This Regulatory Affairs Executive / Senior Executive -IVD role at PROMEA THERAPEUTICS PRIVATE LIMITED is based in Hyderabad. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Executive / Senior Executive -IVD role at PROMEA THERAPEUTICS PRIVATE LIMITED full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Regulatory Affairs Executive / Senior Executive -IVD role at PROMEA THERAPEUTICS PRIVATE LIMITED.
How do I apply for the Regulatory Affairs Executive / Senior Executive -IVD position at PROMEA THERAPEUTICS PRIVATE LIMITED?
Click the "Apply Now" button on this page. You will be redirected to PROMEA THERAPEUTICS PRIVATE LIMITED's official application portal hosted on greythr where you can submit your application directly.
When was the Regulatory Affairs Executive / Senior Executive -IVD job at PROMEA THERAPEUTICS PRIVATE LIMITED posted?
This Regulatory Affairs Executive / Senior Executive -IVD position at PROMEA THERAPEUTICS PRIVATE LIMITED was posted on Jul 8, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Executive / Senior Executive -IVD
PROMEA THERAPEUTICS PRIVATE LIMITED
You'll be redirected to PROMEA THERAPEUTICS PRIVATE LIMITED's official application page on greythr.