Regulatory Affairs Specialist (URGENT)

We are seeking a detail-oriented Regulatory Affairs Specialist to support the registration and ongoing compliance of our medical device and pharmaceutical products. The role will coordinate regulatory submissions, maintain product documentation, and liaise with relevant government agencies and internal teams to help ensure products meet applicable requirements.

Key Responsibilities

• Prepare, compile, review, and submit regulatory documents for product registration, renewals, amendments, and other required approvals.
• Support FDA registration activities for medical devices and pharmaceutical products, including tracking application status and responding to requests for additional information.
• Maintain accurate regulatory files, product records, licenses, certificates, and submission trackers.
• Monitor changes to applicable regulations and guidance, and help assess how they affect the company’s products and processes.
• Coordinate with manufacturers, principals, suppliers, consultants, and internal departments to obtain required documents and resolve regulatory issues.
• Work with quality, procurement, sales, and product teams to ensure regulatory documentation is complete and current.
• Assist with labeling, product information, and promotional-material reviews for regulatory compliance.
• Support audits, inspections, and other compliance activities by preparing records and coordinating follow-up actions.
• Conduct field work as needed, which may include visiting government offices, facilities, or business partners to follow up on regulatory matters.
• Provide timely updates on submission progress, regulatory risks, and outstanding requirements.

Qualifications

• At least 1–2 years of relevant work experience in regulatory affairs, product registration, or a related field.
• Experience with FDA registration is preferred, particularly for both medical devices and pharmaceutical products.
• Familiarity with regulatory submissions, product documentation, and compliance recordkeeping.
• Strong organizational skills and attention to detail, with the ability to manage multiple applications and deadlines.
• Clear written and verbal communication skills and confidence coordinating with internal and external stakeholders.
• Proficiency in Microsoft Office and document-management tools.
• Willingness to undertake field work and travel when required.
• A relevant degree in pharmacy, life sciences, medical technology, or a related discipline is an advantage.