Technical Documentation (España)

Technical Documentation (España)

13 sep
|
ALTEN Delivery Centre Spain
|
España

13 sep

ALTEN Delivery Centre Spain

España

*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 adaptable 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- Identify missing, incomplete or outdated documentation and define remediation actions.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.
- Support the preparation and adaptation of technical documentation required for registration activities in China.
- 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 Dev

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

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