Regulatory Affairs Specialist II

"Are you a detail-oriented and driven individual looking to make a meaningful impact in the world of healthcare? Look no further! Thermo Fisher Scientific is seeking a highly motivated Regulatory Affairs Specialist II to join our dynamic team. As a global leader in scientific research and development, we are dedicated to improving the lives of millions through innovative solutions. In this role, you will play a key role in ensuring compliance with regulatory requirements and supporting the development and commercialization of life-saving products. If you have a strong understanding of regulatory guidelines and a passion for making a difference, we want to hear from you!"

1. Ensure compliance with all regulatory requirements: The Regulatory Affairs Specialist II will be responsible for staying up to date on all relevant regulations and guidelines related to the development and commercialization of healthcare products. They will work closely with cross-functional teams to ensure that all processes and procedures are in line with regulatory standards.
2. Participate in product development and commercialization: This role will involve working closely with product development teams to provide regulatory guidance and support throughout the entire product lifecycle. The Regulatory Affairs Specialist II will be responsible for reviewing and approving all product-related documentation to ensure regulatory compliance.
3. Conduct regulatory research and analysis: The individual in this role will be expected to conduct extensive research and analysis of regulatory guidelines and requirements. They will need to stay up to date on any changes or updates and communicate them to relevant teams.
4. Prepare and submit regulatory submissions: The Regulatory Affairs Specialist II will be responsible for preparing and submitting all necessary regulatory submissions, including applications, reports, and registrations. They will also ensure that all submissions are accurate, complete, and submitted within the required timelines.
5. Maintain records and documentation: This role requires meticulous record-keeping and documentation. The individual will be responsible for maintaining all regulatory records and documents, ensuring they are organized and easily accessible for audits and inspections.
6. Collaborate with cross-functional teams: The Regulatory Affairs Specialist II will work closely with cross-functional teams, including R&D, quality assurance, and legal, to ensure that all products and processes are compliant with regulatory requirements.
7. Support audits and inspections: The individual in this role will be responsible for supporting audits and inspections by regulatory agencies or internal auditors. They will provide all necessary documentation and assist in addressing any findings or recommendations.
8. Stay informed on industry trends and changes: It is crucial for the Regulatory Affairs Specialist II to stay informed on industry trends, changes, and best practices related to regulatory affairs. They will be expected to continuously improve processes and procedures to ensure compliance and efficiency.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist II in Singapore is between SGD 70,000 - SGD 100,000 per year. This range may vary depending on factors such as experience, industry, and company size.

Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.