Regulatory and Quality Manager

Job Description :

Work Schedule

Environmental Conditions

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

DESCRIPTION:

Join our collaborative team at Thermo Fisher Scientific as a Regulatory Affairs and Quality Manager. The incumbent will lead the overall Thermo Fisher Singapore regulatory and quality system with primary focus with the Research and Safety Division.

DESCRIPTION

You'll guide strategic regulatory initiatives for our innovative portfolio of laboratory equipment, consumables, chemicals and reagents. Working closely with cross-functional teams, particularly the commercial teams to ensure regulatory compliance both internal and with customers. This role offers the opportunity to shape regulatory strategy, interact with local health authorities, customers and drive excellence in compliance in the regulatory framework. He/she will also lead the EHS safety and compliance and manage any related EHS licenses as needed. You will also be responsible for managing the ISO 9001 processes and certification as well as customer and internal audits.

REQUIREMENTS

• Bachelor's Degree plus 6 and more years of experience in regulatory affairs in medical device, IVD, pharmaceutical or life science channel distributor.
• Preferred Fields of Study: Life Sciences, Chemistry, Biology, Pharmacy or related scientific field
• Professional certifications in Regulatory Affairs (RAC) beneficial
• Experience in managing ISO9001 and a Certified ISO 9001 internal auditor.
• Comprehensive knowledge of local and global regulations and guidelines and submission requirements.
• Strong experience managing regulatory submissions and agency interactions
• Highly experienced in managing ISO 9001 certification and preferably be a certified internal auditor
• Advanced project management and organizational skills
• Demonstrated leadership ability and experience managing regulatory teams
• Excellent interpersonal skills for cross-functional collaboration
• Strong analytical and problem-solving capabilities
• Proficiency with regulatory submission tools and documentation systems
• Experience with ISO 9001 quality management systems and GMP requirements
• Ability to interpret and implement new regulatory requirements