Regulatory Assistant

Company Overview

Nyprax Pharma is a growing Regulatory Affairs Consultancy with 20+ years of experience. We provide expert guidance to ensure smooth regulatory submissions for medical devices to be imported, distributed, and marketed in Singapore.

Job Summary

You will coordinate and submit regulatory documentation to the Health Sciences Authority, compile and format medical device dossiers, verify report accuracy, and respond to Ministry queries while managing multiple tasks under deadlines.

Responsibilities

• Coordinate and submit formatted regulatory documents online to the Health Sciences Authority (Ministry of Health)
• Compile client dossiers for medical devices and applications according to Ministry requirements
• Format medical dossier documents to meet regulatory standards
• Verify accuracy of reports through detailed validation and checking
• Respond promptly and accurately to queries from the Ministry of Health
• Manage multiple tasks efficiently under pressure while maintaining attention to detail
• Organize and maintain filing systems and perform ad-hoc administrative duties
• Demonstrate a proactive learning attitude to understand and apply regulatory processes taught in-house
• Meet deadlines consistently and show commitment to personal growth within the company

Required competencies and certifications

• Proficient in English to communicate effectively in regulatory contexts
• Skilled in using Microsoft Office and computer applications to prepare and format documents

Preferred competencies and qualifications

• Diploma holder preferred for foundational knowledge relevant to the role
• Aptitude for learning and adapting to challenges in the healthcare regulatory industry

Other Information

Benefits

• Work hours: Mondays to Fridays, 9am – 6pm
• Location: 59 Ubi Ave 1 Bizlink Centre #07-14, Singapore 408938
• Nearest MRT stations: Ubi Station or MacPherson Station, 7 minutes’ walk
• Remuneration: Starting salary S$2800/month with attractive KPI bonuses
• Environment: Friendly workplace with comprehensive training provided
• Network: Access to a wide network of medical device and IVD clients, from MNCs to SMEs

Contact Bharat Kumar ([email protected])

Company Website www.nypraxpharma.com