Quality & Regulatory Affairs

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

📋 Description

• Assists with QA/RA operations across EMEA and documents regional policies.

• Aids in conducting quality and regulatory assessments and audits in various countries, including gap analysis.

• Oversees CAPA follow-ups on identified issues and supports countries in implementing effective solutions.

• Engages in EMEA QA/RA Management meetings, records minutes, and follows up on agreed actions.

• Organizes virtual, onsite, and offsite regional meetings, handling logistics, agendas, and follow-ups on identified actions.

• Drives and supports multiple projects, monitors timelines, and ensures successful outcomes for EMEA-wide QA/RA initiatives.

• Provides assistance to the PRRC of the EC Representative in Germany for Henry Schein Products by reviewing Quality Agreements.

⛳️ Requirements

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

• Previous experience in Quality Management, Project Management, and familiarity with Medical Device and Pharmaceutical (GDP) practices is advantageous.

• Knowledge of communication with Regulatory Bodies, including MDR/IVDR Regulations, ISO 13485 Validation of computerized systems, and Risk Management (FMEA) is a plus.

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

• Solution-oriented, pragmatic, adaptable, and flexible.

• Capable of working in a matrix, regional environment involving various departments and countries.

• Proficiency in English and strong communication skills along with stakeholder management abilities.

🏝️ Benefits

• Work from Home

• Professional development opportunities