Bachelor's degree in life sciences or related field
Knowledge of eu mdr/ivdr and fda regulations
Experience with regulatory submissions and documentation
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist I to join their team. This role focuses on ensuring product compliance with global regulatory requirements, offering opportunities for professional development within a collaborative and innovative environment
Job Summary
Join the European Regulatory Affairs team to ensure products meet global regulatory requirements and contribute to making the world healthier.
You will compile technical documentation, review regulatory requirements, and support product lifecycle management from initial registration through post-market activities.
This position offers excellent professional development opportunities within an innovative environment focused on serving science.
Matching Summary
Match Score: 85
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist I to join their team. This role focuses on ensuring product compliance with global regulatory requirements, offering opportunities for professional development within a collaborative and innovative environment.
Skills & Requirements
Must-have
Bachelor's Degree in Life Sciences or related field
Knowledge of EU MDR/IVDR and FDA regulations
Experience with regulatory submissions and documentation
Strong technical writing and Microsoft Office skills
Ability to manage multiple projects and meet deadlines
Nice-to-have
Experience with regulatory databases and submission systems
Knowledge of GMP, ISO 13485, and quality management systems
Collaborative mindset in a matrix environment
Customer-focused approach with strong interpersonal skills