Regulatory Affairs Specialist

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**Only candidates who complete the form will be considered. 

Job Description – Regulatory Affairs Specialist 

Location:

Experience Required:

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

Regulatory Affairs Specialist

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, or related field. 
• Minimum

  5 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. 
• Comfortable working independently in a remote environment. 

What We Offer

• Fully remote position with flexible working arrangements. 
• Opportunity to work on diverse projects across multiple international markets. 
• Exposure to global regulatory practices and career growth opportunities. 

Salary

•   Salary will be based on experience, starting from INR 30,000 per month onwards 

Mandatory:

https://forms.office.com/e/vPkmrGDZgE 

**Only candidates who complete the form will be considered.