OMC Medical Limited
Website:
omcmedical.com
Job details:
***IMMEDIATE JOINERS ONLY***
Mandatory: Please fill out the application form here
Regulatory Affairs Specialist Role –Preliminary Screening Form – Fill out form
**Only candidates who complete the form will be considered.
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 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, 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: Please fill out the application form here
Regulatory Affairs Specialist Role –Preliminary Screening Form – Fill out form
**Only candidates who complete the form will be considered.
Click on Apply to know more.
