Quality & Regulatory Affairs – EMEA

This is a fully remote position, open to applicants in Germany.

📋 Description

• Provides support for QA/RA operations across the EMEA region, documenting policies and assisting with the implementation of the EMEA Quality Management System.

• Ensure smooth daily operations, effective communication, and seamless regional oversight of quality-related projects, compliance, and reporting.

• Conduct quality and regulatory visits or audits in various countries, issue gap analyses, ensure follow-up on corrective actions for identified issues, and assist countries in implementing solutions.

• Engage in EMEA QA/RA Management meetings, take minutes, and follow up on agreed actions with the relevant functional or country QA/RA Lead.

• Arrange virtual, onsite, and offsite regional meetings, including managing logistics, agendas, and closely tracking identified actions.

• Lead and support various projects, monitor timelines, and guarantee successful outcomes for QA/RA initiatives across the EMEA region.

• Assist the PRRC of the EC Representative in Germany for Henry Schein Products by reviewing Quality Agreements to clarify the responsibilities of economic operators (Importer/Distributor).

• Provide assistance to the Spanish QA/RA Team regarding Quality-related matters to ensure compliance with GDP and MDR.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.

• Prior experience in Quality Management.

• Experience in Project Management.

• Familiarity with Medical Device and Pharmaceutical (GDP) regulations is advantageous.

• Experience communicating with Regulatory Bodies.

• Knowledge of MDR/IVDR Regulations and ISO 13485.

• Validation experience with computerized systems.

• Risk management knowledge (FMEA) is a plus.

• Experience in implementing and maintaining Quality System processes to comply with ISO 13485:2016, GDP, and MDR.

• Ability to operate effectively in a matrix, regional environment with various departments and countries.

• Proficiency in English, strong communication skills, and effective stakeholder management.

🏝️ Benefits

• Health insurance

• Remote work options