Regulatory Affairs Specialist Ii (ivd/medical Devices)
Thermo Fisher Scientific UK
Hybrid
Bachelor's degree plus 2 years experience
Strong knowledge of anvisa regional regulations
Experience preparing regulatory submissions
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist II to support compliance and market access for their diagnostic solutions. The ideal candidate will have relevant experience in regulatory affairs within the IVD/medical device industry, with strong organizational and communication skills
Job Summary
This role ensures product compliance and market access for innovative diagnostic solutions within a global team.
The specialist will manage regulatory submissions, maintain product registrations, and support quality management systems across international markets.
Employees contribute to the mission of making the world healthier by developing solutions for challenges like cancer cures and food safety.
Matching Summary
Match Score: 85
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist II to support compliance and market access for their diagnostic solutions. The ideal candidate will have relevant experience in regulatory affairs within the IVD/medical device industry, with strong organizational and communication skills.
Skills & Requirements
Must-have
Bachelor's Degree plus 2 years experience
Strong knowledge of ANVISA regional regulations
Experience preparing regulatory submissions
Intermediate English and basic Spanish required
Nice-to-have
ANATEL regulatory knowledge desirable
Life Sciences or Pharmacy background preferred
M&A regulatory impact assessment skills
Cross-functional team collaboration abilities
Key Requirements
Bachelor's Degree in Life Sciences or related field