Senior Specialist, Quality and Regulatory Affairs

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

📋 Description

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

• Document EMEA policies and aid in the implementation of the EMEA Quality Management System.

• Conduct quality and regulatory visits and/or audits, perform gap analyses, and ensure follow-up and documentation for CAPA.

• Aid countries in the implementation of quality and regulatory solutions.

• Organize regional meetings, whether virtual, onsite, or offsite, including managing logistics, agendas, and action follow-ups.

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

• Assist in managing multiple EMEA-wide projects, tracking timelines, and ensuring successful outcomes.

• Maintain the eQMS and Quality Document Management Tool.

• Oversee change control activities and ensure timely closure of CAPA follow-ups.

• Provide support to country QA/RA teams regarding quality topics and compliance with GDP and MDR.

• Implement regulatory requirements and initiatives for continuous improvement.

• Support transformation projects and activities related to product launches.

• Assist in the rollout of eQMS implementation in designated countries.

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

• Conduct and oversee training on quality and compliance communications.

• Assist with PRRC and EC Representative responsibilities, including adverse event reporting, post-market surveillance, and FSN management.

• Travel regularly, with trips up to 30% of the time.

⛳️ Requirements

• Experience in quality management and project management.

• Background in the medical device industry.

• Experience in pharmaceuticals/GDP is advantageous.

• Familiarity with MDR/IVDR regulations and ISO 13485.

• Knowledge of computerized system validation and risk management (FMEA) is a plus.

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

• Understanding of Quality Management Systems and Project Management.

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

• A solution-oriented, pragmatic, adaptable, and flexible approach.

• Ability to operate within a matrix regional environment across various departments and countries.

• Proficient in English.

• Excellent written and spoken English skills.

• Strong communication and stakeholder management abilities.

• Capability to balance time pressures with regulatory demands.

• Ability to manage confidential information appropriately.

• Advanced oral and written communication skills.

• Willingness to travel regularly, with trips up to 30% of the time.

🏝️ Benefits

• Work From Home arrangement.

• Opportunity to engage in a diverse and inclusive environment.

• Chances to develop and contribute authentically.

• Opportunities to give back to society and local communities.

• Reasonable accommodations available during the application process.