Regulatory Affairs Assistant

About the Role

We are looking for a detail-oriented and proactive Regulatory Affairs Assistant to support medical device registration and regulatory activities in Sri Lanka. The ideal candidate will have practical experience in medical device registration and NMRA requirements and will support the preparation of regulatory documentation, submissions, follow-ups, application tracking and coordination with manufacturers, suppliers, authorized representatives and internal teams.

Key Responsibilities

• Handle and support medical device registration, renewal, variation, and related NMRA requirements.
• Prepare, review, and organize regulatory documents required for medical device submissions.
• Visit NMRA frequently for submissions, follow-ups, clarifications, meetings, and document collection.
• Track application status, regulatory queries, pending documents, and approval timelines
• Coordinate with manufacturers, suppliers, authorized representatives, and internal teams to obtain required documentation.
• Follow up on NMRA deficiencies, additional information requests, and regulatory correspondence.
• Maintain accurate regulatory trackers and records of all submissions and follow-ups.
• Stay updated on NMRA requirements, guidelines, and changes relevant to medical devices.

Requirements

• Degree or Diploma in Pharmacy, Biomedical Science, Medical Laboratory Science, Life Sciences, Regulatory Affairs, or a related field.
• 2–3 years of hands-on experience in medical device registration and regulatory affairs.
• Practical experience handling NMRA Sri Lanka medical device registration requirements is strongly preferred.
• Familiarity with technical and regulatory documents such as product specifications, certificates, declarations, labels, IFUs, and manufacturer documentation.
• Strong communication, follow-up, documentation, and organizational skills.
• Good written and spoken English; Sinhala proficiency is preferred.
• Willingness and ability to visit NMRA frequently as part of the role.

Why Join Us

Join Bridge Health, where specialist expertise and practical solutions come together to address complex challenges across pharmaceutical and regulated manufacturing environments. You will have the opportunity to work in a growing, internationally connected organization supporting regulatory and healthcare operations across markets.