QA & Regulatory Specialist, East Asia (Hybrid)

Stryker; Singapore; Hybrid; SGD 70,000 - 110,000; Full time

Job summary

Stryker is seeking a Quality Assurance professional to support the East Asia QMS implementation and ongoing compliance with regulatory requirements. The role involves handling product complaints, field actions, adverse event reporting, and coordinating with local manufacturing teams to ensure timely closure and adherence to ISO 13485 and local standards.

The candidate will assist in document control, training management, and KPI monitoring, while ensuring awareness of regulatory changes and

Qualifications

• Requires a Bachelor's degree in Pharmacy, Biomedical Sciences or related field.
• Experience in medical device, healthcare, or pharmaceutical industry preferred.
• Knowledge of quality management systems and regulations (ISO 13485, GDPMDS, GDPMD) preferred.

Responsibilities

• Support the implementation and maintenance of the QMS in East Asia.
• Manage Product Complaints, Holds, FSCAs/PFAs, and Adverse Event reporting with local teams.
• Support regulatory reporting for submissions to local authorities.
• Assist document control activities including change management and training.
• Monitor quality KPIs and assist with periodic reporting.
• Support internal and external audits preparation.

Skills

Quality mindset

Attention to detail

Communication

Independent

Organizational skills

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or Biomedical Sciences

Job description

Stryker is seeking a Quality Assurance professional to support the East Asia QMS implementation and ongoing compliance with regulatory requirements. The role involves handling product complaints, field actions, adverse event reporting, and coordinating with local manufacturing teams to ensure timely closure and adherence to ISO 13485 and local standards.

The candidate will assist in document control, training management, and KPI monitoring, while ensuring awareness of regulatory changes and