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BXF-278 - Quality Assurance Regulatory Affairs Manager (Buen Salario)

Detalles del Trabajo

Ibiza, Balearic Islands, España
elemed
24.07.2025
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Descripción completa del puesto

Title: Senior Manager QARA

Location: Italy or Spain

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

Contract length: Interim - 3-6 months - Immediate Start

Contact: ******

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

Interested? Send your CV directly to ****** or view all open positions at Elemed. 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, 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.

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