Global Life Sciences: Docs & Regulatory Specialist (Remote)

ALTEN Delivery Centre Spain; España; Remote; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Remote work possibility

Flexible schedule

International project

Job summary

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.

Responsibilities

• 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• Identify missing or outdated documentation and define remediation actions.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.

Skills

Regulatory compliance

Technical documentation

Cross-functional collaboration

Regulatory frameworks knowledge

Education

Degree in Engineering, Life Sciences, Medical Technology

Job description

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.