Are you looking for the next challenge in your career?

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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 adaptable 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- Identify missing, incomplete or outdated documentation and define remediation actions.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. xsgfvud

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