Remote Senior QA & Regulatory Affairs Specialist, EMEA

Henry Schein; España; Remote; EUR 90,000 - 130,000; Full time

Job summary

Henry Schein is seeking a Senior QA/RA professional to support EMEA-wide quality and regulatory operations, document EMEA policies, and manage CAPA follow-up, reporting to the Snr. Director QA/RA EMEA. The role is remote, based in Spain or Germany, with up to 30% travel.

Key duties include audits, change control oversight, eQMS maintenance, GDP/MDR compliance, and cross-country collaboration with QA/RA leads across the EMEA region.

Qualifications

• Experience in Quality Management and Project Management within Medical Devices.
• GDP experience is a plus.
• MDR/IVDR regulations and ISO 13485 knowledge required/advantageous.
• Validation of computerized systems and risk management (FMEA) knowledge is a plus.

Responsibilities

• Support EMEA QA/RA operations and document EMEA policies.
• Coordinate quality/regulatory visits, CAPA follow-up, and gap analyses.
• Organize regional meetings and ensure timely follow-ups with country QA/RA leads.
• Assist the Exec. Director QA/RA EMEA and the EMEA QA/RA team.
• Oversee eQMS maintenance and document management.
• Ensure compliance with GDP and MDR across countries.

Skills

Quality Management

Project Management

Regulatory Affairs

MDR/IVDR

GDP Knowledge

Risk Management

Validation of Computerized Systems

eQMS & Document Control

Education

Bachelor's degree in Life Sciences / Pharmacist / Biomedical Engineering / Business Management

Tools

eQMS

Job description

Henry Schein is seeking a Senior QA/RA professional to support EMEA-wide quality and regulatory operations, document EMEA policies, and manage CAPA follow-up, reporting to the Snr. Director QA/RA EMEA. The role is remote, based in Spain or Germany, with up to 30% travel.

Key duties include audits, change control oversight, eQMS maintenance, GDP/MDR compliance, and cross-country collaboration with QA/RA leads across the EMEA region.