Experience in regulatory activities for ivd products
Practical experience with eu or apac regulatory requirements
Ability to interact with regulatory authorities and notified bodies
The Regulatory Affairs Senior Specialist is responsible for executing and coordinating global regulatory activities for in vitro Diagnostics (IVD) products
Job Summary
The Regulatory Affairs Senior Specialist is responsible for executing and coordinating global regulatory activities for in vitro Diagnostics (IVD) products.
Key responsibilities include supporting product launches, market expansion, and lifecycle management while ensuring compliance with global regulatory requirements.
The role requires monitoring regulatory changes, communicating with authorities, and representing Regulatory Affairs in cross-functional projects.
Matching Summary
The Regulatory Affairs Senior Specialist is responsible for executing and coordinating global regulatory activities for in vitro Diagnostics (IVD) products.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Experience in regulatory activities for IVD products
Practical experience with EU or APAC regulatory requirements
Ability to interact with regulatory authorities and Notified Bodies
Nice-to-have
Global regulatory project coordination experience
Strong regulatory writing skills
Experience interacting with global regulatory stakeholders
Key Requirements
Experience in regulatory activities for IVD products
Experience with regulatory requirements in at least one region
Proficiency in English for regulatory documentation