Regulatory Affairs Specialist

OMC Medical Limited; Tamil Nadu; On-site; INR 800,000 - 1,200,000; Full time

Benefits offered by this job

Office-based role

Diverse international projects

Career growth opportunities

Job summary

OMC Medical Pvt Ltd in India is seeking a Regulatory Affairs Specialist to manage product registrations and regulatory submissions across international markets.

The role requires 5+ years of regulatory experience, strong knowledge of EU MDR, US FDA, and other global frameworks, and willingness to relocate from India to Dubai for an office-based role. You will work with Quality, Sales, and Regulatory consultants to ensure audit readiness and timely licenses.

Qualifications

• Minimum 3–5 years of regulatory affairs experience in medical devices or pharmaceuticals
• Strong knowledge of EU MDR, US FDA, SAHPRA, CDSCO, NRCS, etc.
• Proven experience in preparing and submitting regulatory dossiers
• Excellent written and verbal communication, highly organized and proactive

Responsibilities

• Prepare, compile, and submit product registration dossiers to regulatory authorities worldwide
• Manage regulatory filings, renewals, amendments, and variations across jurisdictions
• Maintain an up-to-date database of licenses, certificates, and approvals
• Monitor regulatory changes and advise on compliance strategies
• Collaborate with Quality, Sales, Operations, and external consultants for timely submissions
• Provide regulatory input for new product introductions and market expansion
• Ensure documentation is audit-ready and compliant with global standards
• Liaise with external consultants, regulatory agencies, and distributors

Skills

Regulatory affairs

Regulatory submissions

Attention to detail

Education

Bachelor's or Master's in Pharmacy/Life Sciences/Biomedical Eng

Job description

Job Description – Regulatory Affairs Specialist

Location: India (Mandatory requirement to relocate from India to Dubai, UAE - Work from Office)

Experience Required: Minimum 5 years

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 strong 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, and 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, or a related field.
• Minimum 3 years of regulatory affairs experience in the medical device or pharmaceutical industry.
• Strong understanding of international regulatory frameworks (EU MDR, US FDA, SAHPRA, CDSCO, NRCS, etc.).
• Proven experience in preparing and submitting regulatory dossiers.
• Excellent written and verbal communication skills.Highly organized, detail-oriented, and proactive, with the ability to manage multiple projects simultaneously.
• Ability to work independently and effectively in an office environment.

What We Offer

• Full-time office-based position.
• Opportunity to work on diverse projects across multiple international markets.
• Exposure to global regulatory practices and career growth opportunities.

Salary will be based on experience and qualifications.