Regulatory Affairs Senior Specialist (H/F)
Integra LifeSciences
Job 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... ).
+ Manage the back and forth with the National Competent Authorities and Notified Bodies, including activities as the UK, Switzerland and EU Authorized Representative and Importer (MDD 93/42 or MDR 2017/745).
+ Secure the regulatory conformit...
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... ).
+ Manage the back and forth with the National Competent Authorities and Notified Bodies, including activities as the UK, Switzerland and EU Authorized Representative and Importer (MDD 93/42 or MDR 2017/745).
+ Secure the regulatory conformit...