Quality Assurance Regulatory Affairs Manager

elemed; Donostia/San Sebastián; Presencial; EUR 80.000 - 110.000; Jornada completa

Descripción de la vacante

A leading global MedTech organization is seeking a Senior Manager RAQA for Europe to drive regulatory strategies and enforce compliance across Western and Southern Europe. This strategic role involves ensuring alignment with regulations, leading a cross-functional team, and implementing quality management processes.

Formación

• Minimum 12 years’ experience in Regulatory Affairs & Quality Assurance for medical devices.
• Deep knowledge of EU (MDR), Spanish, Italian, Portuguese regulations, ISO 13485, and FDA standards.
• Fluency in English plus Spanish and/or Italian.

Responsabilidades

• Provide strategic direction for Regulatory Affairs, Quality Assurance, and Post-Market activities.
• Lead governance meetings, reporting performance, risks, and issues to regional leadership.
• Manage RAQA integration for new acquisitions and system harmonisation.

Conocimientos

Communication

Decision-making

Stakeholder Management

Educación

Bachelor’s degree in Engineering, Life Sciences, or related field

Master’s degree (preferred)

Descripción del empleo

You may be required to travel on 3-4 days per month.

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
• 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 - You may be required to travel on 3-4 days per month.

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.