Senior Executive (Regulatory Affairs)

Senior Executive (Regulatory Affairs) – Delmege Group

Job Overview

Job Title: Senior Executive – Regulatory Affairs – Device
Company: Delmege Forsyth & Co. Ltd.
Industry: Healthcare / Medical Devices
Location: Sri Lanka

Job Description

Delmege is seeking a passionate and experienced professional to join its team as a Senior Executive – Regulatory Affairs – Device. The role focuses on managing medical device registrations and ensuring compliance with NMRA regulatory requirements.

Key Responsibilities

• Handle end-to-end medical device registration with NMRA.
• Prepare, review, and submit device dossiers in compliance with NMRA guidelines.
• Coordinate and follow up with NMRA officials regarding submissions, queries, and approvals.
• Liaise with principals/manufacturers to obtain required documentation.
• Maintain regulatory documentation and ensure timely renewals and variations.
• Ensure strong communication and coordination throughout the registration process.
• Maintain a high level of attention to detail and regulatory compliance.
• Work effectively under pressure and meet deadlines.
• Demonstrate flexibility and willingness to work extra hours when required.

Qualifications & Experience

• Pharmacist or Non-Pharmacist candidates are encouraged to apply.
• Proven experience in medical device registration.
• Strong knowledge of NMRA regulatory requirements and medical device dossier submission processes.
• Hands-on experience in:
  • NMRA follow-ups
  • Dossier preparation
  • Regulatory coordination
• Ability to manage multiple product registrations and meet timelines efficiently.

How to Apply

📧 Submit your CV to:
careers@delmege.com

Subject: Mention the position name in the subject line.

Delmege Forsyth & Co. Ltd.
101, Vinayalankara Mawatha, Colombo 10.