MEDTECH OFFICER

Do you want to join in our team and work with our Medical Device unit? Do you want to apply your knowledge in RA & medical device?We are waiting for you! Main Responsabilities:Work with direct reports to develop successful global regulatory strategies to ensure timely device approvals: roadmaps, viability analysis, clinical evaluation, risk managementGuide clients in decisions concerning medical device product development and promotionCollect and coordinate information and prepare regulatory documentation for submission to different regions worldwide (EU, USA, etc.): technical file preparation & review (CE marking), FDA clearance (510(k)) and premarket approval (PMA)Communication with notified bodiesBusiness development and marketing activitiesEstablishing processes and working instructionRequirements:Degree in biological/pharmaceutical sciences or biomedical engineering.1-2 years’ experience in RA & Technical Documentation - Medical DevicesPrevious experience in Research&Development or in Project Management will be a plus.High level of English and Spanish.Curious and interested about technological innovation, product development and regulationsFocused and with rigorous mindsetOrganised and with strong attention to detailCapable of self-learning in new fields and in complex projects with multiple stakeholdersWe offer you: A highly, dynamic & international working environment with employees from more than 15 nationalities. A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship. Training and personal development program. Flexible working schedule - Compacted workday on Friday. Social Benefits: English lessons, wellbeing programme, flexible remuneration. Home Office - Hybrid Model Permanent contract.