Quality Assurance Regulatory Affairs Manager

elemed; Marbella; Presencial; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

A leading global MedTech organization is seeking a Senior Manager RAQA for Europe to oversee regulatory strategies and quality assurance for medical devices. This role involves leading a cross-functional team, ensuring compliance with regulations while driving continuous improvements and managing audits. Candidates should have substantial experience in regulatory affairs, strong leadership skills, and be willing to travel.

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 required.

Responsabilidades

• Provide strategic direction for RAQA activities across Europe.
• Lead governance meetings and manage integration for new acquisitions.
• Plan and lead internal and external audits.

Conocimientos

Leadership

Communication

Stakeholder Management

Regulatory Knowledge

Educación

Bachelor's degree in Engineering, Life Sciences

Master's 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.