About the role

Aplyr's Quick Take

This role is about overseeing regulatory compliance and quality management for laboratory products at Thermo Fisher in Singapore. You'll lead regulatory initiatives, manage ISO 9001 processes, and work closely with various teams to ensure adherence to regulations. It's a managerial position focused on strategy and compliance rather than hands-on technical work.

Good fit

Ideal candidates have over 6 years of experience in regulatory affairs, particularly in life sciences or medical devices. Strong leadership skills and a collaborative working style are essential, along with a background in project management and regulatory submissions.

Worth noting

The role requires a deep understanding of both local and global regulations, which could be a steep learning curve for those not already familiar. The emphasis on ISO 9001 management suggests a structured environment, but the posting lacks specifics on team size and dynamics.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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

Aplyr's read

Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
Synthesized from recent postings & public sources

What's promising

•Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
•The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
•Global presence provides diverse career opportunities across multiple regions and disciplines.

What to watch

•High pressure and fast-paced environment may not suit everyone.
•Complex organizational structure can lead to communication challenges.
•Frequent acquisitions may result in uncertainty and change for employees.

Why Thermo Fisher

•Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
•The company plays a crucial role in global scientific advancements and healthcare solutions.
•Strong focus on sustainability and corporate responsibility sets it apart in the industry.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Thermo Fisher

Thermo Fisher

thermofisher.com

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Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.