As Senior Expert Regulatory Affairs, you will develop and implement global regulatory pathways for product authorizations and oversee the preparation and submission of regulatory documents to authorities
Job Summary
As Senior Expert Regulatory Affairs, you will develop and implement global regulatory pathways for product authorizations and oversee the preparation and submission of regulatory documents to authorities.
Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation, and maintain and update regulatory documentation related to Quality Management Systems.
Become part of a team that shapes a future in which clear vision and professional success go hand in hand, offering diverse career paths and products.
Matching Summary
As Senior Expert Regulatory Affairs, you will develop and implement global regulatory pathways for product authorizations and oversee the preparation and submission of regulatory documents to authorities.
Skills & Requirements
Must-have
global regulatory pathways
product authorizations
regulatory compliance
product labeling
clinical trials support
marketing claims assessment
Nice-to-have
customer and result oriented focus
multicultural environment proficiency
digital processes in RA
clear vision and professional success
Key Requirements
BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs
Experience in medical device software and IEC 62304
Experience with notified bodies and regulatory authorities in Europe