Quality Assurance Regulatory Affairs Manager

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

Descrizione del lavoro

A leading global MedTech organization is seeking a Senior Manager RAQA for Europe based in Prato, Italy. This strategic role involves overseeing regulatory strategies, ensuring compliance with local and international standards, and leading a cross-functional team. The ideal candidate will have substantial experience in regulatory affairs for medical devices, strong leadership skills, and the ability to manage complex stakeholder relationships. Expectations include a proactive approach to ensuring the highest quality standards across Western and Southern Europe.

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 plus Spanish and/or Italian.

Mansioni

• Provide strategic direction for Regulatory Affairs and Quality Assurance.
• Lead governance meetings and manage RAQA metrics.
• Plan and lead internal and external audits.

Conoscenze

Leadership

Communication

Stakeholder Management

Decision Making

Formazione

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

Master’s degree (preferred)

Descrizione del lavoro

You will be required to travel during this period.

Contact :

The Company, a leading global MedTech organization, is strengthening its footprint across Western and Southern Europe, ensuring its portfolio of medical device 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 harmonization.
• 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 up to 20% across the region.

Interested?

Send your CV directly to [contact email] or view all open positions at [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.

Position: Quality Assurance Manager • Prato, Italia