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Job Description – Regulatory Affairs Specialist

Location:
Remote (India)

Experience Required:
Minimum 5 year

About OMC Medical Pvt Ltd

OMC Medical Pvt Ltd is a leading provider of regulatory and compliance services for Medical Devices, Cosmetics, Pharmaceuticals, and Food Supplements. Our services include UK MHRA Registration, Brexit Customs Clearance, Global Product Registrations, Translations, Labeling, and Software Registration for medical devices.

Role Overview

We are looking for an experienced
Regulatory Affairs Specialist
to join our team. The role involves managing product registrations, regulatory submissions, and licenses across multiple international markets. The right candidate will bring solid knowledge of global regulatory frameworks and proven experience in handling end-to-end submissions for medical devices.





Key Responsibilities
- Prepare, compile, and submit product registration dossiers to regulatory authorities worldwide.
- Manage regulatory filings, renewals, amendments, and variations across different jurisdictions.
- Maintain an up-to-date database of licenses, certificates, and approvals, ensuring timely renewals.
- Monitor and interpret changes in international regulatory requirements and advise on compliance strategies.
- Collaborate with cross-functional teams (Quality, Sales, Operations, external consultants) to support timely submissions.
- Provide regulatory input for new product introductions and market expansion projects.
- Ensure documentation is audit-ready and compliant with global standards.
- Act as a liaison with external consultants, regulatory agencies, and distributors.

Qualifications & Skills
- Bachelor's or master's degree in pharmacy, Life Sciences, Biotechnology, Biomedical Engineering,

📌 Regulatory Affairs Specialist (India)
🏢 OMC Medical
📍 India