Regulatory Affairs Specialist (m/f/d)

Are you a detail-oriented and highly organized individual with a passion for ensuring compliance with regulatory standards? Do you have experience in the life sciences industry and a strong understanding of regulatory requirements? If so, we have an exciting opportunity for you to join our team as a Regulatory Affairs Specialist at Thermo Fisher Scientific. As a member of our Regulatory Affairs team, you will play a crucial role in ensuring our products meet all necessary regulatory requirements, allowing us to bring life-saving technologies to market. If you are looking for a challenging and rewarding career in a dynamic and innovative company, then we invite you to apply for this role.

1. Ensure compliance with regulatory standards: The primary responsibility of the Regulatory Affairs Specialist will be to ensure that all products and processes meet the necessary regulatory standards, both domestically and internationally.
2. Stay updated on regulatory changes: The specialist will be responsible for staying up-to-date on any changes in regulatory requirements and communicating these changes to the appropriate teams within the company.
3. Conduct research and analyze data: The specialist will be responsible for conducting research and analyzing data to ensure that all products and processes comply with regulatory requirements.
4. Develop and maintain regulatory procedures: The specialist will be responsible for developing and maintaining procedures to ensure compliance with regulatory standards. This may include creating and revising documentation, as well as conducting internal audits.
5. Collaborate with cross-functional teams: The specialist will work closely with various departments, such as R&D, Quality Assurance, and Production, to ensure that all regulatory requirements are met throughout the product development and manufacturing processes.
6. Prepare and submit regulatory submissions: The specialist will be responsible for preparing and submitting all necessary regulatory documents, including product registrations, applications, and reports.
7. Facilitate communication with regulatory agencies: The specialist will serve as the primary point of contact for all communication with regulatory agencies, ensuring that all inquiries and requests are addressed in a timely and accurate manner.
8. Ensure timely product approvals: The specialist will work diligently to ensure that all necessary regulatory approvals are obtained in a timely manner, allowing the company to bring products to market as quickly as possible.
9. Conduct trainings: The specialist may be responsible for conducting trainings for employees on regulatory requirements and procedures, ensuring that everyone is aware of their responsibilities in maintaining compliance.
10. Monitor and maintain regulatory compliance: The specialist will be responsible for continuously monitoring and maintaining regulatory compliance of all products and processes, including conducting regular audits and implementing corrective actions when necessary.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist (m/f/d) in 79 Freiburg im Breisgau, Germany is €70,000 - €90,000 per year. This may vary depending on the specific company, industry, and level of experience of the individual. Additionally, benefits and bonuses may also affect the overall salary package.

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.