QARA, Assistant Manager

Canon Medical Systems Asia Pte Ltd; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading medical technology company in Singapore is seeking a qualified individual for the Quality Assurance & Compliance, Regulatory Affairs, and EHS roles. The ideal candidate has a Bachelor’s degree in Life Sciences or related fields and 5+ years of relevant experience. Responsibilities include overseeing the Integrated Management Systems, managing regulatory submissions, and ensuring compliance with quality standards. Strong communication skills and regulatory knowledge specific to ASEAN markets are essential. This position is vital for maintaining safety and compliance across the organization, benefiting both employees and customers.

Qualifications

• 5+ years of experience in Quality Assurance and/or Regulatory Affairs, preferably in the pharmaceutical, medical device, or healthcare industry.
• Familiarity with regulatory requirements in Singapore, Vietnam, and Thailand.
• Preferably knowledgeable in quality management systems and ISO standards.

Responsibilities

• Oversee the organisation's Integrated Management Systems (IMS).
• Lead the renewal and maintenance of ISO certifications.
• Conduct ISO and compliance-related training.

Skills

Excellent communication skills

Strong organizational skills

Project management skills

Attention to detail

Proficiency in MS Office

Education

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field

Job description

Canon Medical Systems Asia is a subsidiary of Canon Medical Systems Corporation, a global medical technology company that develops and produces diagnostic imaging systems, including CT, MRI, ultrasound, X-ray, and healthcare IT solutions. Canon Medical Systems Asia is based in Singapore and serves customers throughout the Asia-Pacific region.

You should possess excellent communication skills and be a team player, with the ability to take initiative and work independently.

Quality Assurance & Compliance (Integrated Management Systems)

• Oversee the organisation’s Integrated Management Systems (IMS), encompassing Quality Management Systems (QMS), Occupational Health & Safety Management Systems (OHSMS), Environmental Management Systems (EMS), and broader compliance requirements.
• Lead the renewal and maintenance of the company’s ISO certifications, ensuring readiness for all certification and surveillance audits.
• Conduct ISO and compliance-related training to build employee awareness and ensure adherence to regulatory and quality requirements.
• Ensure all organisational processes and systems meet applicable quality, safety, environmental, and regulatory standards, including ISO 9001, ISO 14001, ISO 45001, and GDPMDS.
• Drive internal and external audit activities, ensuring audit documentation, findings, corrective actions, and follow-ups are completed accurately and on schedule.
• Provide guidance and support to teams on quality standards, compliance expectations, and industry best practices.
• Partner with cross-functional departments to support quality and compliance initiatives such as CAPA management, non-conformance reporting, risk assessments, and root cause analysis aligned with ISO and regulatory requirements.
• Coordinate with IMS document owners to ensure SOPs, work instructions, and controlled documents comply with ISO and regulatory standards, and are routinely reviewed and updated.
• Maintain comprehensive documentation and records to support certification, surveillance, and regulatory inspections.
• Monitor updates to relevant ISO standards and compliance regulations, ensuring timely implementation of changes across the organisation.

Regulatory Affairs (RA)

• Ensure all company products, processes, and systems comply with relevant quality standards and regulatory requirements.
• Manage the preparation and timely submission of regulatory documents for markets in Singapore, Vietnam, and Thailand, ensuring compliance with local laws and regulations.
• Liaise with local regulatory agencies and maintain open communication to stay informed of any regulatory changes.
• Collaborate with internal teams to collect necessary data and documentation for submissions.
• Monitor and track regulatory timelines to ensure submissions are completed on schedule.
• Maintain regulatory files and records to ensure that all information is accurate, up-to-date, and readily accessible.
• Provide regulatory guidance to cross-functional teams on product development and market strategies.

Environment, Health, and Safety (EHS)

• Actively participate in the EHS team to ensure the organization adheres to environmental, health, and safety standards.
• Support the development and implementation of risk management strategies to mitigate potential EHS‑related hazards.
• Conduct risk assessments and collaborate with the EHS team to identify and minimize workplace hazards.
• Drive continuous improvement initiatives in EHS practices, ensuring compliance with local and international EHS regulations.
• Provide guidance and training to employees on safety protocols, hazard identification, and risk mitigation.
• Assist in incident investigations, ensuring that root causes are identified and corrective actions are effectively implemented.

Qualifications and Desired Background in a Candidate

1. Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
2. 5+ years of experience in Quality Assurance and/or Regulatory Affairs, preferably in the pharmaceutical, medical device, or healthcare industry.
3. Familiarity with regulatory requirements in Singapore, Vietnam, and Thailand.
4. Preferably with knowledge of quality management systems, ISO standards (e.g., ISO 9001, 14001, 45001 and 13485) and GDPMDS GMP regulations.
5. Strong organizational and project management skills.
6. Excellent attention to detail and the ability to multitask in a fast‑paced environment.
7. Effective communication skills and the ability to collaborate across departments.
8. Proficiency in MS Office and relevant software tools for document management.

Special Competencies Requirement

• Experience in managing submissions for ASEAN markets.
• Familiarity with local regulations and industry standards in the medical or healthcare sector.
• Certification in Regulatory Affairs or Quality Assurance is a plus.