Job Description
WE ARE HIRING!
REGULATORY AFFAIRS OFFICER
MEDICAL DEVICES & HEALTHCARE PRODUCTS
Colombo, Sri Lanka • Full-Time
ABOUT US
Sethmedi International (Pvt) Ltd is a healthcare solutions provider in Sri Lanka, partnering with international manufacturers to supply quality medical devices, surgical instruments, medical equipment and healthcare products to the local healthcare sector. We are looking for a proactive, detail-oriented Regulatory Affairs Officer to manage and coordinate our regulatory activities and support the continued growth of our healthcare product portfolio.
KEY RESPONSIBILITIES
- Handle medical device registrations, renewals, variations and related regulatory submissions with NMRA.
- Prepare, review and maintain regulatory dossiers and supporting technical documentation in compliance with NMRA requirements.
- Liaise with NMRA officials and follow up on applications, approvals, regulatory queries and pending submissions.
- Coordinate with overseas manufacturers and suppliers to obtain required regulatory certificates, technical documents and clearances.
- Maintain accurate records of product registrations, import-related regulatory approvals, licences and renewal deadlines.
- Monitor changes in regulatory guidelines and ensure timely compliance.
- Coordinate with internal teams to support product registration priorities and business requirements.
QUALIFICATIONS & EXPERIENCE
- Degree or relevant professional qualification in Pharmacy, Biomedical Science, Biological Sciences, Chemistry or a related discipline.
- 1-3 years of relevant experience in regulatory affairs, preferably in medical devices or healthcare products.
- Practical knowledge of NMRA medical device registration procedures, dossier preparation and regulatory documentation.
- Familiarity with Free Sale Certificates FSC, ISO 13485, manufacturer authorizations and related technical documentation.
- Excellent communication skills in English, both written and verbal.
- Good organizational skills, attention to detail and proficiency in MS Office applications.
- Ability to work independently, coordinate with multiple stakeholders and meet deadlines.
- Willingness to visit NMRA and other relevant authorities whenever required.
ADDED ADVANTAGE
- Previous experience independently handling NMRA medical device registrations and regulatory authorizations.
WHY JOIN US
- Exposure to international healthcare manufacturers and medical technologies.
- Opportunity to develop specialized regulatory expertise.
- A collaborative working environment with career growth opportunities.
- An attractive remuneration package commensurate with qualifications and experience.
APPLY NOW
- Interested candidates are invited to send their updated CV mentioning Regulatory Affairs Officer in the subject line to [email protected]
- Only shortlisted candidates will be contacted.
