Quality Assurance Regulatory Affairs Manager

Title :

Senior Manager QARA Location :

Italy or SpainYou may be required to travel on 3-4 days per month.⌛ Contract length :

Interim - 3-6 months - Immediate Start✉️ Contact :

The CompanyA leading global MedTech organisation is strengthening its footprint across Western and Southern Europe, ensuring its portfolio of medical devices products meets the highest standards.The OpportunityAs 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.You’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.Key responsibilities :

• Provide strategic direction for Regulatory Affairs, Quality Assurance, and Post-Market activities across Western and Southern EuropeLead governance meetings, reporting performance, risks, and issues to regional leadershipDevelop, monitor, and report RAQA metrics;
• drive continuous process improvementsManage RAQA integration for new acquisitions and system harmonisationAct as primary liaison with Competent Authorities, Notified Bodies, and Trade AssociationsPlan and lead internal and external audits, ensuring timely closure of findingsDefine and cascade KPIs, objectives, and targets;
• recruit, mentor, and develop high-performing talentEnsure environmental management compliance where applicable, including local reporting and management reviewsPartner closely with Operations, Sales, and other business functions to support product launches and lifecycle managementRequirementsBachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred)Minimum 12 years’ experience in Regulatory Affairs & Quality Assurance for medical devicesLeadership experienceDeep knowledge of EU (MDR), Spanish, Italian, Portuguese regulations, ISO 13485, and FDA standardsFluency in English plus Spanish and / or ItalianProven track record as a transformational leader, with strong communication, decision-making, and stakeholder management skillsWillingness to travel - You may be required to travel on 3-4 days per month.Interested? Send your CV directly to or view all open positions atOnly candidates who meet the criteria will be contacted;

if you don’t hear back within 10 days, please consider your application unsuccessful.