Quality Assurance Regulatory Affairs Manager

elemed; Vercelli; In loco; EUR 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading global MedTech organization is seeking a Senior Manager for Regulatory Affairs and Quality Assurance in Europe. This strategic interim position, lasting 3-6 months, involves ensuring compliance with medical device regulations and oversight of quality management systems. The ideal candidate will bring extensive experience in the field and strong leadership capabilities while also guiding a team and collaborating across various business functions.

Competenze

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

Mansioni

• Provide strategic direction for Regulatory Affairs and Quality Assurance.
• Lead governance meetings and report performance to regional leadership.
• Develop and report RAQA metrics.

Conoscenze

Leadership

Communication

Decision-making

Stakeholder management

Formazione

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

Master's degree (preferred)

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

• 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 up to 20% across the region

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.