Are you looking for the next challenge in your career? ¿Interesado en saber más sobre este trabajo? Desplácese hacia abajo y descubra qué habilidades, experiencia y cualificaciones académicas se necesitan. 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.
* Long-term secure contract.
* International Project with top technologies
* Possibility of working remotely with a flexible schedule.
* Integration in a highly qualified team of professionals.
* Travel abroad with your project.
* Specialized training and continuous professional development.
* Social benefits and versátil 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* Identify missing, incomplete or outdated documentation and define remediation actions.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 documentation requirements.
* Experience with Design History Files (DHF), Technical Documentation, Design Control and Risk Management documentation.
* Familiarity with ISO 13485, MDR and international regulatory frameworks.
* Strong analytical and organizational skills.
* Ability to work in cross-functional and international project environments. Nice to Have:
* Experience with international registration projects.
* Experience in gap assessments and documentation remediation activities.
* Knowledge of requirements traceability, document control and quality management systems. We positively value all work or study experience abroad. xqysrnh All positions require a high level of English (at least B2)
- please send your detailed CV in English.

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