Bachelor's degree in life sciences or related field
6+ years regulatory affairs experience
Medical device, ivd, pharmaceutical or life science distributor
The position of Regulatory and Quality Manager at Fisher Scientific Pte Ltd in Singapore involves leading regulatory and quality initiatives primarily for the Research and Safety Division. The candidate will focus on regulatory compliance, managing ISO 9001 processes, and collaborating with cross-functional teams to ensure adherence to local and global regulations
Job Summary
The role involves leading the overall regulatory and quality system for Thermo Fisher Singapore with a primary focus on the Research and Safety Division.
Incumbents will guide strategic regulatory initiatives for an innovative portfolio of laboratory equipment, consumables, chemicals, and reagents while ensuring compliance with local health authorities.
This position requires managing ISO 9001 processes, certifications, and audits alongside EHS safety compliance and license management.
Matching Summary
Match Score: 85
The position of Regulatory and Quality Manager at Fisher Scientific Pte Ltd in Singapore involves leading regulatory and quality initiatives primarily for the Research and Safety Division. The candidate will focus on regulatory compliance, managing ISO 9001 processes, and collaborating with cross-functional teams to ensure adherence to local and global regulations.
Skills & Requirements
Must-have
Bachelor's Degree in Life Sciences or related field
6+ years regulatory affairs experience
Medical device, IVD, pharmaceutical or life science distributor
ISO 9001 certification management
Local and global regulatory submission expertise
Nice-to-have
RAC professional certification
Certified ISO 9001 internal auditor status
Strong cross-functional collaboration skills
Experience with EHS safety compliance
Advanced project management capabilities
Key Requirements
Bachelor's Degree plus 6+ years experience
Experience in medical device, IVD, pharma, or life science distribution