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.

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- 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:

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- Identify missing, incomplete or outdated documentation and define remediation actions.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

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- 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:

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- 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. xcskxlj

All positions require a high level of English (at least B2) - please send your detailed CV in English.

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📌 Technical Documentation & Regulatory Compliance Specialist -Life Science - International Project (España)
🏢 ALTEN Delivery Centre Spain
📍 España