Regulatory Affairs Specialist EMEA (H/F)
Integra LifeSciences • Saint Priest, France
Role Description
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
**RESPONSIBILITIES**
**PRODUCT REGISTRATIONS**
+ Plan, coordinate and maintain the registrations in accordance with the objectives defined by the Top Management and the EMEA Business Division; to obtain approvals on time
+ Prepare / write / update submission files to obtain UE / EMEA certificate of market access (CE mark, UKCA, Swiss regulation, Egypt, Saudi Arabia, Morocco, Algeria... )..
+ Secure the regulatory conformity of the EMEA Sales entities.
+ Maintain up to date registration indicator in the EMEA.
+ Do an evaluation of changes done for a product and its manufacturing process to indicate regulatory impacts.
...
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
**RESPONSIBILITIES**
**PRODUCT REGISTRATIONS**
+ Plan, coordinate and maintain the registrations in accordance with the objectives defined by the Top Management and the EMEA Business Division; to obtain approvals on time
+ Prepare / write / update submission files to obtain UE / EMEA certificate of market access (CE mark, UKCA, Swiss regulation, Egypt, Saudi Arabia, Morocco, Algeria... )..
+ Secure the regulatory conformity of the EMEA Sales entities.
+ Maintain up to date registration indicator in the EMEA.
+ Do an evaluation of changes done for a product and its manufacturing process to indicate regulatory impacts.
...