Are you looking for the next challenge in your career?

Would you like to be part of an exciting highly qualified team of professionals in an international environment?

We are currently looking for a qualified Technical Documentation & Regulatory Compliance Specialist

Join an international division and work alongside some of the most talented engineers and technicians from all over the world.

Your benefits:

• Competitive Salary.
• Long-term secure contract.
• International Project with top technologies
• Possibility of working remotely with a versátil schedule.
• Integration in a highly qualified team of professionals.
• Travel abroad with your project.
• Specialized training and continuous professional development.
• Social benefits and flexible compensation plan.

Responsibilities:

• Review and assess existing product documentation, technical files and regulatory records.
• Support the execution of regulatory and technical gap analyses between current documentation and NMPA requirements.
• Develop and maintain traceability matrices linking product requirements,



risk management files, verification activities and regulatory documentation.
• Identify missing, incomplete or outdated documentation and define remediation actions.
• Coordinate documentation activities across engineering, quality, regulatory affairs and external stakeholders.
• Ensure consistency across product specifications, design history files, risk management documentation and quality records.
• Contribute to the development of document structures, templates and governance processes to ensure efficient document management.
• Support the preparation of submission packages and registration-related deliverables.

Requirements:

• Degree in Engineering, Life Sciences, Medical Technology or a comparable discipline.
• Experience working in regulated industries, preferably Medical Devices, Diagnostics or Life Sciences.
• Strong understanding of technical documentation structures and regulatory document

📌 Technical Documentation (España)
🏢 ALTEN Delivery Centre Spain
📍 España