Quality Assurance Regulatory Affairs Manager

elemed; Vigo; Presencial; EUR 80.000 - 110.000; Jornada completa

Descripción de la vacante

A leading global MedTech organization is looking for a Senior Manager RAQA for Europe to provide strategic direction in regulatory affairs and quality assurance. This role involves leadership in ensuring compliance and managing post-market activities across multiple countries. The ideal candidate will bring over 12 years of experience in medical devices, excellent communication skills, and a proven leadership track record.

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.
• Define and cascade KPIs, objectives, and targets.

Conocimientos

Leadership

Communication

Decision-making

Stakeholder management

Educación

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

Master’s degree (preferred)

Descripción del empleo

Italy or Spain. You may be required to travel 3-4 days per month.

Contact :

The Company: A leading global MedTech organization is strengthening its footprint across Western and Southern Europe, ensuring its portfolio of medical devices meets the highest standards.

The Opportunity

As a Senior Manager RAQA for Europe, you will report to the Europe Director and support a cross-functional team responsible for market access (importation, distribution, maintenance) and ongoing compliance.

You will 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

1. Provide strategic direction for Regulatory Affairs, Quality Assurance, and Post-Market activities across Western and Southern Europe.
2. Lead governance meetings, reporting performance, risks, and issues to regional leadership.
3. Develop, monitor, and report RAQA metrics; drive continuous process improvements.
4. Manage RAQA integration for new acquisitions and system harmonization.
5. Act as primary liaison with Competent Authorities, Notified Bodies, and Trade Associations.
6. Plan and lead internal and external audits, ensuring timely closure of findings.
7. Define and cascade KPIs, objectives, and targets; recruit, mentor, and develop high-performing talent.
8. Ensure environmental management compliance where applicable, including local reporting and management reviews.
9. Partner closely with Operations, Sales, and other 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 (3-4 days per month).

Interested?

Send your CV directly or view all open positions at Elemed. 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, specializing 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.