Quality & Regulatory Affairs 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

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.