The Senior Regulatory Affairs Specialist is responsible for supporting global regulatory compliance of Medical Devices placed on the market by Cytiva
Job Summary
The Senior Regulatory Affairs Specialist is responsible for supporting global regulatory compliance of Medical Devices placed on the market by Cytiva.
This role involves managing assessments related to product change control and overseeing global processes for regulatory activities such as product complaints and supply disruption reporting.
Candidates must possess a Life Sciences degree or equivalent along with comprehensive knowledge of Quality Systems ensuring compliance with ISO standards.
Matching Summary
Match Score: 85
The Senior Regulatory Affairs Specialist is responsible for supporting global regulatory compliance of Medical Devices placed on the market by Cytiva.
Skills & Requirements
Must-have
2-3 years healthcare regulatory experience
Knowledge of ISO 13485 and ISO 9001
Fluency in English and Polish languages
Experience with EU MDR (Regulation 2017/745)
Medical device product change control
Nice-to-have
Ability to present technical information clearly
Experience with RIM system implementation
Strong attention to detail
Collaborative team culture fit
Willingness to travel within EMEA region
Key Requirements
Life Sciences degree or equivalent
2-3 years experience in healthcare/life sciences
Comprehensive knowledge of ISO 9001 and ISO 13485
Working knowledge of global medical device regulations