Quality Assurance Regulatory Affairs Manager

elemed; Latina; In loco; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading global MedTech organisation seeks a Senior Manager for Regulatory Affairs and Quality Assurance across Europe. In this strategic role, you’ll ensure compliance with local regulations and lead a cross-functional team driving innovation in medical devices. An ideal candidate possesses over 12 years of experience, a degree in a relevant field, and fluency in multiple languages. This role requires strong leadership skills and the ability to communicate effectively with stakeholders.

Competenze

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

Mansioni

• Provide strategic direction for Regulatory Affairs, Quality Assurance, and Post-Market activities.
• Lead governance meetings and report performance to regional leadership.
• Plan and lead internal and external audits.

Conoscenze

Regulatory Affairs

Quality Assurance

Stakeholder Management

Leadership

Decision Making

Communication

Formazione

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

Master’s degree (preferred)

Strumenti

ISO 13485

MDR

FDA standards

Descrizione del lavoro

Italy or Spain - You will be required to travel during this period.

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.

Additional responsibilities:

• 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.

Leadership and collaboration:

• 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 up to 20% across the region.

Interested? Send your CV directly to the contact provided or view all open positions at our website.

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, 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.