The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.
Thermo Fisher Scientific Inc. seeks a Regulatory Affairs Specialist II in Singapore to join the Asia Pacific regulatory affairs (RA) team for the in-vitro diagnostics product range for sale in Asia Pacific markets. This role offers a chance to play a part in regulatory processes and compliance, ensuring product quality and safety.
Responsibilities
Compile and review technical documentation for product registrations in Southeast Asia (SEA) countries.
Review and edit dossiers to meet countries’ requirements, ensuring the accuracy and consistency of information.
Support SEA countries’ channel partners in complying strictly with local regulations.
Collaborate with internal and external partners to address regulatory obstacles.
Respond to questions related to product registration and change notification from regulatory agencies.
Keep track of license validity in SEA countries and ensure licenses are renewed in a timely manner.
Stay on top of regulatory requirements and developments, monitor and work with internal/external collaborators to ensure seamless product supply.
Provide input for regulatory change assessments to determine the impact on registrations.
Handle Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
Assist in QMS maintenance and internal/external audits.
Support GMP certificate renewals in countries where applicable.
Requirements
Bachelor’s degree or equivalent experience in a relevant field.
2 - 5 years in regulatory affairs roles in medical devices or in-vitro diagnostics industry.
Outstanding organizational skills with the ability to manage multiple tasks.
Strong communication and interpersonal skills.
Ability to adapt and succeed in a fast-paced environment.
Dedication to excellence and a high level of integrity.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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"Quality is everyone's responsibility. Right the first time should not be only a metric, but a lifestyle."
Elaine Director, Regulatory Affairs, Latin America, Specialty Diagnostics
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