Social network you want to login/join with:Quality Assurance Regulatory Affairs Manager, SienaClient: elemedLocation: Italy or Spain (Travel required)Job Category: OtherEU work permit required: YesJob Reference:7171370987928158208337159Job Views:2Posted:24.06.2025Expiry Date:08.08.2025Job Description:A leading global MedTech organisation is strengthening its footprint across Western and Southern Europe, ensuring its portfolio of medical devices meets the highest standards.The OpportunityAs a Senior Manager RAQA for Europe, you will support the leadership of a cross-functional team responsible for market access, compliance, and regulatory strategies throughout the product lifecycle, including registration, post-market surveillance, and quality management system processes.Key Responsibilities:Provide strategic direction for Regulatory Affairs, Quality Assurance, and Post-Market activities in Western and Southern EuropeLead governance meetings, report performance, risks, and issues to regional leadershipDevelop and monitor RAQA metrics and drive process improvementsManage RAQA integration for acquisitions and system harmonisationAct as liaison with authorities, Notified Bodies, and Trade AssociationsPlan and lead audits, ensuring timely closure of findingsDefine KPIs, objectives, and develop high-performing talentEnsure environmental compliance and local reportingCollaborate with Operations, Sales, and other functions for product launches and lifecycle managementRequirements:Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred)At least 12 years of experience in Regulatory Affairs & Quality Assurance for medical devicesDeep knowledge of EU MDR, Spanish, Italian, Portuguese regulations, ISO 13485, and FDA standardsFluency in English plus Spanish and/or ItalianProven leadership, communication, decision-making, and stakeholder management skillsWillingness to travel up to 20% across the regionInterested? Send your CV to [emailprotected] or view all open positions at https://www.elemed.eu/vacancies/Only candidates meeting the criteria will be contacted; if you don’t hear back within 10 days, please consider your application unsuccessful.About ElemedElemed is Europe’s leading MedTech technical recruiter, specialising in Quality, Regulatory, Clinical, and R&D roles, placing experts from Manager to VP level.Elemed is an equal opportunity employer, celebrating diversity and fostering an inclusive environment for all candidates and contractors.
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