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:
The 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 management
Requirements
* 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 region
Interested? Send your CV directly to or view all open positions at
Only candidates who meet the criteria will be contacted; if you don’t hear back within 10 days, please consider your application unsuccessful.