Regulatory & Import Officer (with Office Administration)

About the role

OMC Medical is a UK-based regulatory consultancy supporting medical device, pharmaceutical, cosmetics and IVD companies with product registration and compliance worldwide. It is opening its Colombo office and is looking for a hands-on regulatory professional to run it day to day. You will prepare and manage NMRA registrations, handle import permits and keep the office running smoothly, working closely with teams in the UK, Dubai and India.

Key responsibilities

• Regulatory (NMRA): prepare, compile and submit registration dossiers to the National Medicines Regulatory Authority for medical devices, pharmaceuticals and cosmetics
• Track application status, respond to NMRA queries and manage renewals and variations
• Review client documents for completeness and compliance before submission, and maintain registration records, certificates and expiry trackers
• Liaise with clients and OMC regulatory teams on requirements and timelines
• Import permits and logistics: apply for and manage import permits and licenses, coordinate with clearing agents, freight forwarders and customs, check shipping documents and track shipments
• Office administration: manage records, filing, supplies, utilities and vendors, handle visits to government offices, support management with scheduling and correspondence, and coordinate with the accounts team on invoices and expenses

Required profile

• Degree in pharmacy, life sciences, biomedical engineering or a related field
• 2-5 years' experience in regulatory affairs, import and licensing or a similar role
• Working knowledge of NMRA processes strongly preferred
• Excellent written and spoken English; Sinhala and/or Tamil desirable
• Desirable: knowledge of medical device regulation or ISO 13485, and experience with customs clearance or import licensing

Required skills

• Proficiency in Microsoft Office (Word, Excel, Outlook)
• Strong organization, attention to detail and follow-through on deadlines
• Comfortable working independently and across time zones

What we offer

• A competitive salary
• The chance to build a new office from the ground up
• Training and exposure to regulatory work across multiple international markets