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.
Responsabilidades e Atribuições
- Manage product registrations and maintain compliance documentation.
- Support regulatory submissions across international markets.
- Compile technical documentation and review regulatory requirements.
- Support product lifecycle management from initial registration through post-market activities.
- Collaborate with Quality Assurance, R&D, Commercial teams, and regulatory authorities to ensure compliance.
- Facilitate efficient product launches and maintain existing approvals.
Requisitos e Qualificações
- 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.
