Title:Senior Manager QARA
Location:Italy or Spain -You will be required to travel during this period
⌛Contract length:Interim - 3-6 months - Immediate Start
✉️Contact:ahmed@elemed.euThe Company
A 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 Opportunity
As 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 Europe
Lead governance meetings, reporting performance, risks, and issues to regional leadership
Develop, monitor, and report RAQA metrics; drive continuous process improvements
Manage RAQA integration for new acquisitions and system harmonisation
Act as primary liaison with Competent Authorities, Notified Bodies, and Trade Associations
Plan and lead internal and external audits, ensuring timely closure of findings
Define and cascade KPIs, objectives, and targets; recruit, mentor, and develop high-performing talent
Ensure environmental management compliance where applicable, including local reporting and management reviews
Partner closely with Operations, Sales, and other business functions to support product launches and lifecycle managementRequirements
Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred)
Minimum 12 years’ experience in Regulatory Affairs Quality Assurance for medical devices
Leadership experience
Deep knowledge of EU (MDR), Spanish, Italian, Portuguese regulations, ISO 13485, and FDA standards
Fluency in English plus Spanish and/or Italian
Proven track record as a transformational leader, with strong communication, decision-making, and stakeholder management skills
Willingness to travel up to 20% across the regionInterested?Send your CV directly to ahmed@elemed.eu or view all open positions at https://www.elemed.eu/vacancies/
Only candidates who meet the criteria will be contacted; if you don’t hear back within 10 days, please consider your application unsuccessful.
About Elemed
Elemed 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.
⚖️ Elemed is an equal opportunity employer. We celebrate diversity and foster an inclusive environment for all candidates and contractors.