Regulatory Affairs Specialist / BDE
OMC Medical Ltd
Posted 2 days ago
Job Details
Location: India (Mandatory requirement to relocate from India to Dubai, UAE - Work from Office)Experience Required: Minimum 5 years
Mandatory: Please fill out the application form herehttps://forms.cloud.microsoft/Pages/ResponsePage.aspx?id=zcqF-aEt5E2wRgAuPjTCTvfIGxlFhzdDqWGza5VVOClUN05DSjNOWk5WMk03TElPTUFLWDhRVzRFSyQlQCN0PWcu
**Only candidates who complete the screening form will be considered.
About OMC Medical Pvt LtdOMC 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.
SalarySalary will be based on experience and qualifications.
Mandatory: Please fill out the application form herehttps://forms.cloud.microsoft/Pages/ResponsePage.aspx?id=zcqF-aEt5E2wRgAuPjTCTvfIGxlFhzdDqWGza5VVOClUN05DSjNOWk5WMk03TElPTUFLWDhRVzRFSyQlQCN0PWcu
**Only candidates who complete the screening form will be considered**
Mandatory: Please fill out the application form herehttps://forms.cloud.microsoft/Pages/ResponsePage.aspx?id=zcqF-aEt5E2wRgAuPjTCTvfIGxlFhzdDqWGza5VVOClUN05DSjNOWk5WMk03TElPTUFLWDhRVzRFSyQlQCN0PWcu
**Only candidates who complete the screening form will be considered.
About OMC Medical Pvt LtdOMC 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.
SalarySalary will be based on experience and qualifications.
Mandatory: Please fill out the application form herehttps://forms.cloud.microsoft/Pages/ResponsePage.aspx?id=zcqF-aEt5E2wRgAuPjTCTvfIGxlFhzdDqWGza5VVOClUN05DSjNOWk5WMk03TElPTUFLWDhRVzRFSyQlQCN0PWcu
**Only candidates who complete the screening form will be considered**
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