Define regulatory strategies and pathways.
Establish TF s for all classes I-II
Prepare FDA submissions
Submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.
Support design and development of products from a regulatory perspective.
Advise on standards, labelling and UDI requirements.
Participates in internal and external audits i.e. FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP.
3+ years’ related experience in the medical device industry.
Experience in certified QMS environment per ISO13485 / FDA-QSR.
Bachelor's degree or higher in life science-related discipline, engineering, or law
Excellent English proficiency