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)