Quality Assurance Regulatory Affairs Manager

elemed; Málaga; Presencial; EUR 80.000 - 120.000; Jornada completa

Descripción de la vacante

A leading global MedTech organization is seeking a Senior Manager for Regulatory Affairs and Quality Assurance. This strategic role involves ensuring compliance for medical devices across Western and Southern Europe, overseeing market access and defining quality processes aligned with ISO standards. The ideal candidate should have extensive experience in regulatory affairs and a proven record in leadership within the MedTech industry.

Formación

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

Responsabilidades

• Provide strategic direction for Regulatory Affairs, Quality Assurance, and Post-Market activities.
• Lead governance meetings, manage RAQA integration for new acquisitions, and ensure compliance.
• Define KPIs, recruit, mentor, and develop high-performing talent.

Conocimientos

Regulatory Affairs

Quality Assurance

Stakeholder Management

Leadership

Communication

Educación

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

Master’s degree (preferred)

Descripción del empleo

Quality Assurance Regulatory Affairs Manager Quality Assurance Regulatory Affairs Manager

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Associate Director | Contract Recruiter | MedTech | Digital Health | elemed

Location : Italy or Spain

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

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
• 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.

Elemed is Europe’s leading MedTech technical recruiter, specialising in Quality, Regulatory, Clinical, and R&D 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.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Contract

Job function

• Job function Quality Assurance, Legal, and Distribution
• Industries Medical Equipment Manufacturing and Biotechnology Research

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