Regulatory affairs manager | executive

Company: Surgipharma Pvt Ltd — a leading medical device company in Sri Lanka

Role: Regulatory Affairs Manager/Executive

Key responsibilities:

– Manage regulatory submissions, registrations, renewals, and approvals

– Ensure compliance with applicable medical device regulations

– Maintain regulatory dossiers, technical documentation, and records

– Monitor regulatory changes and provide guidance on compliance

– Coordinate with foreign suppliers

Key requirements:

– Degree in Pharmacy, Life Sciences, Chemistry, or a related field

– Strong experience in Regulatory Affairs and medical device regulations

– Knowledge of quality systems, documentation control, and change management

– Excellent analytical, organisational, and communication skills

– Experience dealing with regulatory authorities in Sri Lanka is an advantage

Details:

– Location: No.17, John Keells Housing Scheme, Enderamulla, Wattala

– Full-time, on-site

– Apply email: [email protected]