Remote Regulatory Submission Lead – IVD

Mira; Barcelona; Remote; EUR 81,000 - 116,000; Full time

Benefits offered by this job

Competitive salary

Performance-based bonus systems tiedto

Fully remote

Job summary

Mira seeks a Regulatory Submission Specialist to lead regulatory documentation for IVD devices. You will ensure clinical, analytical, usability, risk-management, quality, and labeling evidence is compiled into submission-ready materials and supports compliance across the product lifecycle.

The ideal candidate has experience in regulatory submissions, technical documentation, and international IVD regulatory requirements, with strong writing, project management, and cross-functional coordination

Qualifications

• Bachelor degree in Regulatory Affairs, Biomedical Science, or related field.
• 2+ years in regulatory affairs for medical devices or IVDs, incl. preparing technical documentation or submissions.
• Experience with EU IVDR CE-marking documentation and ISO 13485 standards.

Responsibilities

• Prepare and maintain IVD regulatory submission dossiers and technical documentation.
• Review labels, IFU, product claims for regulatory alignment.
• Assess analytical and clinical-performance evidence to support claims.

Skills

Technical writing

Project management

Stakeholder coordination

Independent work

Education

Bachelor degree in Regulatory Affairs or related discipline

Tools

Regulatory documentation tools

Job description

Mira seeks a Regulatory Submission Specialist to lead regulatory documentation for IVD devices. You will ensure clinical, analytical, usability, risk-management, quality, and labeling evidence is compiled into submission-ready materials and supports compliance across the product lifecycle.

The ideal candidate has experience in regulatory submissions, technical documentation, and international IVD regulatory requirements, with strong writing, project management, and cross-functional coordination