Regional QA & Regulatory Affairs Manager (Med Devices)

Private Advertiser; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading life sciences organization is seeking an experienced Quality Assurance & Regulatory Affairs Manager to oversee quality and regulatory functions across Singapore and regional entities. This pivotal role focuses on compliance with international standards, maintaining regulatory certifications, and promoting continuous improvement to enhance healthcare. The ideal candidate will have significant experience in quality management within the life sciences sector and strong leadership skills.

Qualifications

• 5+ years of experience in a medical device, pharmaceutical, or life sciences industry, specifically in Quality and Regulatory functions.
• 5+ years in a supervisory or management role.
• Strong knowledge of ISO standards and GDP/GDPMDS requirements.

Responsibilities

• Define and execute quality and regulatory strategies for Singapore and regional entities.
• Lead, supervise, and train the QA/RA team.
• Oversee all quality and regulatory licenses and certifications.

Skills

Quality and Regulatory functions

ISO 9001:2015

ISO 13485:2016

Analytical skills

Communication skills

Education

Degree in a related Science or Engineering discipline

Job description

A leading life sciences organization is seeking an experienced Quality Assurance & Regulatory Affairs Manager to oversee quality and regulatory functions across Singapore and regional entities. This pivotal role focuses on compliance with international standards, maintaining regulatory certifications, and promoting continuous improvement to enhance healthcare. The ideal candidate will have significant experience in quality management within the life sciences sector and strong leadership skills.