QA/RA Officer

About the role

Join the Quality Assurance / Regulatory Affairs team at a CE‑certified medical device manufacturing unit in Kathmandu. You will help maintain GMP and GDP standards and ensure documentation complies with ISO 13485 and EU MDR requirements.

Key responsibilities

• Maintain and update SOPs, work instructions and other documents required under ISO 13485 and EU MDR.
• Draft, review and ensure accuracy and completeness of regulatory and quality documentation.
• Support preparation of regulatory dossiers for multiple countries.
• Organise records for internal and external audits, inspections and traceability of design or process changes.

Required profile

• Bachelor’s degree in Pharmacy (B.Pharm) from a recognized institution.
• Strong knowledge of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
• 1–2 years experience in a Quality Assurance department preferred; fresh graduates are also encouraged to apply.

Required skills

• Strong attention to detail and excellent documentation skills.
• Understanding of quality and regulatory compliance (ISO 13485, EU MDR).
• Ability to work under pressure, coordinate within a team and communicate effectively.