Technical Documentation & Regulatory Compliance Specialist -Life Science - International Project

ALTEN Delivery Centre Spain; España; À distance; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Remote work possibility

Flexible schedule

International project

Résumé du poste

ALTEN Delivery Centre Spain is seeking a Technical Documentation & Regulatory Compliance Specialist to join an international team. You will review and align product documentation with regulatory requirements, coordinating across engineering, quality and regulatory affairs to ensure DHF integrity.

The role offers a long-term contract, potential remote work with a flexible schedule, and opportunities for cross-cultural collaboration and professional development in a multinational environment.

Qualifications

• Experience with regulatory documentation structures and requirements.
• Familiarity with ISO 13485, MDR and international frameworks.
• Strong analytical and organizational skills.
• Ability to work across engineering, quality, regulatory affairs and external stakeholders.

Responsabilités

• Review and assess existing product documentation, technical files and regulatory records.
• Support regulatory and technical gap analyses between current documentation and MDR/NMPA requirements.
• Develop and maintain traceability linking product requirements, risk management and regulatory documentation.
• Identify missing or outdated documentation and define remediation actions.
• Coordinate documentation activities across cross-functional teams and external stakeholders.
• Ensure consistency across specifications, DHF, risk management and quality records.
• Develop document structures, templates and governance processes for efficient management.
• Support submission packages and registration deliverables.

Connaissances

Regulatory compliance

Technical documentation

Cross-functional collaboration

Regulatory frameworks knowledge

Formation

Degree in Engineering, Life Sciences, Medical Technology

Description du poste

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.

• 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 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 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.

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