Senior Specialist, Quality & Regulatory Affairs

This is a fully remote position, open to applicants in Germany, +4 more countries.

📋 Description

• Assist in quality assurance and regulatory affairs operations across the EMEA region.

• Participate in EMEA QA/RA Management meetings and document policies relevant to the region.

• Aid in the implementation of the EMEA Quality Management System.

• Conduct quality and regulatory visits or audits in various countries and provide gap analyses.

• Ensure proper follow-up and documentation of CAPA, and assist countries in implementing corrective solutions.

• Organize regional meetings, whether virtual, onsite, or offsite, managing logistics and agendas.

• Support the Executive Director of QA & RA for EMEA and the QA/RA Team in the region.

• Manage multiple projects, monitor timelines, and ensure successful execution of EMEA-wide initiatives.

• Maintain the electronic Quality Management System (eQMS) and the Quality Document Management Tool.

• Supervise change-control activities and CAPA follow-ups to ensure timely closure.

• Assist country QA/RA teams in compliance with GDP and MDR, regulatory implementation, continuous improvement, transformation projects, and product launches.

• Facilitate the rollout of eQMS implementations in designated countries.

• Support initiatives for inspection readiness and the deployment of necessary tools.

• Conduct and oversee training on quality and compliance communications.

• Support PRRC and EC Representative duties, including adverse-event reporting, post-market surveillance, and FSN management.

• Willingness to travel frequently, up to 30% of the time.

⛳️ Requirements

• Proven experience in Quality Management, Project Management, and within the Medical Devices sector.

• Experience in pharmaceuticals (GDP) is advantageous.

• Familiarity with MDR/IVDR Regulations and ISO 13485 standards.

• Understanding of computerized-system validation and risk management (FMEA) is beneficial.

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

• Strong knowledge of Quality Management Systems and Project Management principles.

• Experience in implementing and maintaining quality-system processes that comply with ISO 13485:2016, GDP, and MDR requirements.

• Ability to navigate a matrix regional environment involving various departments and countries.

• Proficient in written and spoken English.

• Excellent communication and stakeholder management abilities.

• Capacity to balance time constraints with regulatory demands.

• Competence in handling confidential information appropriately.

• Strong oral and written communication skills.

🏝️ Benefits

• Opportunity to work from home.

• Home-based position.

• Regular travel opportunities up to 30%.

• Engagement in virtual, onsite, and offsite regional meetings.