You’ll be working hand-to-hand with the Head of RAQA and the aim is for you to progress and be able lead key project (FDA approval, CE mark):
Support all regulatory activities associated with the development, post-approval and life-cycle
Support product registration in target countries
Prepare U.S. FDA, EU and international submissions
Develop and execute regulatory strategies/plans that comply with global regulatory requirements
Ensure Regulatory Affairs files are maintained to support compliance with regulatory requirements
Supporting Regulatory review of Ad and Promo materials;
Support the team with interpretation of regulations and guidance, as well as process support, as needed.
Support internal and external audits as required.
Drafting and maintaining regulatory policies, procedures, and SOPs as required;
Support for QMS activities
Engineering Degree or MsC in Regulatory Affairs or Medical/Scientific field
3-6 years of experience in a regulatory affairs position for medical devices
Familiar with EU regulation (MDR 2017/745) and QMS regulation (ISO 13485, 21 CFR)
Great capacity for relational adaptation to integrate a young dynamic team
Great technical skills and operational excellence
Strong teamwork and communication skills, efficient and well-organized with excellent attention to detail and ability to manage a diverse workload
Capability to formalize and manage transversal projects
Proactivity and will to achieve ambitious goals
Transparency, humility and respect
Good level of English (written/oral)
Tyto společnosti rovněž nabírají pracovníky na pozici "{profese}".