PuLocation : /u Italy or Spain - You will be required to travel during this period /ppuContract length : /u Interim - 3-6 months - Immediate Start /ppbContact : The Company /b /ppA leading global MedTech organisation is strengthening its footprint across Western and Southern Europe, ensuring its portfolio of medical devices products meets the highest standards. /ppbThe Opportunity /b /ppAs a Senior Manager RAQA for Europe, you’ll report to the Europe Director and support the leadership of a cross-functional team responsible for market access (importation, distribution, maintenance) and ongoing compliance. /ppYou’ll support regulatory strategies throughout the product lifecycle, from pre-market submissions and product registrations (including change management) to post-market surveillance and CAPA initiatives. This strategic role also owns the Quality Management System processes, ensuring alignment with ISO 13485, local regulations, and internal SOPs. /ppbKey responsibilities : /b /pulliProvide strategic direction for Regulatory Affairs, Quality Assurance, and Post-Market activities across Western and Southern Europe /liliLead governance meetings, reporting performance, risks, and issues to regional leadership /liliDevelop, monitor, and report RAQA metrics; drive continuous process improvements /liliManage RAQA integration for new acquisitions and system harmonisation /liliAct as primary liaison with Competent Authorities, Notified Bodies, and Trade Associations /liliPlan and lead internal and external audits, ensuring timely closure of findings /liliDefine and cascade KPIs, objectives, and targets; recruit, mentor, and develop high-performing talent /liliEnsure environmental management compliance where applicable, including local reporting and management reviews /liliPartner closely with Operations, Sales, and other business functions to support product launches and lifecycle management /li /ulpbRequirements /b /pulliBachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred) /liliMinimum 12 years’ experience in Regulatory Affairs Quality Assurance for medical devices /liliDeep knowledge of EU (MDR), Spanish, Italian, Portuguese regulations, ISO 13485, and FDA standards /liliFluency in English plus Spanish and / or Italian /liliProven track record as a transformational leader, with strong communication, decision-making, and stakeholder management skills /liliWillingness to travel up to 20% across the region /li /ulpInterested? Send your CV directly to or view all open positions at /ppOnly candidates who meet the criteria will be contacted; if you don’t hear back within 10 days, please consider your application unsuccessful. /ppbAbout Elemed /b /ppElemed is Europe’s leading MedTech technical recruiter, specialising in Quality, Regulatory, Clinical, and RD roles. From Manager to VP level, we place experts who drive innovation and compliance in MedTech. /ppElemed is an equal opportunity employer. We celebrate diversity and foster an inclusive environment for all candidates and contractors. /ppQuality Assurance • Venice, Veneto, Italia /p #J-18808-Ljbffr