About the role
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our collaborative team as a Regulatory Affairs Specialist I at Thermo Fisher Scientific, where you'll contribute to ensuring our products meet global regulatory requirements and help make the world healthier, cleaner, and safer. You'll work with cross-functional teams to manage product registrations, maintain compliance documentation, and support regulatory submissions across international markets. This position offers excellent professional development opportunities within our innovative environment focused on serving science.
As a valuable member of our European Regulatory Affairs team, you'll compile technical documentation, review regulatory requirements, and support product lifecycle management from initial registration through post-market activities. You will collect and manage data about chemicals and the CLP classification. You will collaborate with business development and procurement teams to align compliance considerations with strategic goals for portfolio expansion.
You will collaborate with Commercial teams, Customer Service, Suppliers, Quality Assurance, and regulatory authorities to ensure compliance while facilitating efficient product launches and maintaining existing approvals.
REQUIREMENTS:
• Bachelor's Degree required, no prior experience required
• Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
• Additional qualifications in Quality Management or Regulatory Affairs advantageous
• Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements)
• Experience with regulatory submissions and documentation management
• Strong technical writing and documentation skills
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
• Excellent organizational abilities and attention to detail
• Strong analytical and problem-solving capabilities
• Effective verbal and written communication skills in English
• Ability to work both independently and collaboratively in a matrix environment
• Experience with regulatory databases and submission systems preferred
• Knowledge of GMP, ISO 13485, and quality management systems
• Ability to manage multiple projects and meet deadlines
• Customer-focused mindset with strong interpersonal skills
• Demonstrates company values of Integrity, Intensity, Innovation, and Involvement
Skills & Tags
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.
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 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.
