Company Overview

OPH Health Pte. Ltd. is a growing healthcare technology company focused on medical systems, automation and digital healthcare solutions across Southeast Asia.

As we continue to expand our business in Singapore and regional markets such as Indonesia and Malaysia, we are looking for a hands-on Quality & Regulatory Executive / Assistant Manager to support quality system implementation, regulatory coordination, supplier quality and customer quality matters.

This role is suitable for someone who is detail-oriented, practical, willing to learn, and comfortable working in a lean and growing company environment.

Job Summary

The successful candidate will support and coordinate quality and regulatory activities to ensure reliable product deployment and compliant regional expansion.

The role will cover quality documentation, compliance follow-up, regulatory documentation, supplier quality coordination, customer quality issue tracking, and support for applications or maintenance of relevant licences, certifications and qualifications.

As OPH Health is a lean and growing team, the candidate should be hands-on and willing to personally handle documentation, follow-ups and coordination work.

Key Responsibilities

·         Support the setup and maintenance of quality and regulatory processes for healthcare products, medical systems and related solutions.

·         Prepare and maintain SOPs, work instructions, forms, records, quality documents and document control processes.

·         Assist with audit preparation, corrective and preventive actions, non-conformance tracking, risk assessment and compliance follow-up.

·         Support regulatory documentation and product registration activities for Singapore and regional markets, especially Southeast Asia.

·         Coordinate with suppliers, manufacturers, consultants and internal teams to gather required regulatory and quality documents.

·         Track product registrations, licences, certifications, renewals, submission timelines and follow-up actions.

·         Support supplier documentation review, supplier quality follow-up, customer complaint tracking and field quality issue closure.

·         Prepare quality and compliance documents for product delivery, installation, commissioning, customer support, audits, partner onboarding and tender submissions.

·         Support the application, renewal and maintenance of relevant company, product or operational qualifications, licences and certifications.

·         Work closely with management and internal teams to ensure quality and regulatory matters are followed through properly.

Requirements

·         Diploma or Degree in Biomedical Engineering, Life Sciences, Pharmacy, Regulatory Affairs, Quality Management, Engineering or a related discipline.

·         Minimum 2-5 years of relevant experience in quality assurance, regulatory, healthcare products, medical devices, pharmaceutical, life sciences, manufacturing or related industries.

·         Experience in quality documentation, document control, audits, corrective and preventive actions, non-conformance handling or compliance follow-up will be an advantage.

·         Exposure to ISO 13485, ISO 9001, GDP, GDPMDS, GMP or similar quality frameworks will be an advantage.

·         Exposure to HSA registration, medical device registration, product registration or regulatory documentation will be an advantage.

·         Familiarity with Southeast Asian regulatory requirements, especially Indonesia and Malaysia, will be an added advantage but is not mandatory.

·         Strong attention to detail, documentation discipline and follow-through.

·         Able to work independently and manage follow-up actions responsibly.

·         Comfortable working in a lean, fast-paced and evolving company environment.

·         Practical, hands-on and willing to handle documentation and coordination directly.

·         Good communication and coordination skills with internal teams, suppliers, consultants and external stakeholders.

Preferred Attributes

·         Hands-on and willing to learn.

·         Organised, careful and detail-oriented.

·         Able to follow through on tasks from start to closure.

·         Comfortable working in a small team with changing priorities.

·         Proactive in identifying gaps, pending items and required follow-ups.

·         Practical and able to balance compliance requirements with business needs.

·         Interested in healthcare technology, medical systems and regional business expansion.

Why Join Us

·         Opportunity to join a growing healthcare technology company expanding across Southeast Asia.

·         Exposure to quality, regulatory, supplier and customer quality functions.

·         Opportunity to work closely with management and cross-border teams.

·         Suitable for someone who wants to grow into a broader quality and regulatory role.

·         Hands-on role with learning opportunities in healthcare products, medical systems and regional market expansion.