Remote EU IVDR/CE Regulatory Submissions Lead

Mira; Fatih; Remote; TRY 4,936,000 - 6,910,000; Full time

Benefits offered by this job

Remote-friendly

Competitive salary

Career growth

Flexible hours

Bonus program tied to OKRs

Job summary

Mira is seeking a Regulatory Submission Specialist to lead and support the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices. The role ensures evidence across analytical, clinical-performance, and usability remains compliant through the product lifecycle.

This remote role offers collaboration with global teams and a focus on women’s health diagnostics. The ideal candidate has 2+ years in regulatory affairs for medical devices or IVDs, experience with

Qualifications

• Bachelor degree in Regulatory Affairs, Biomedical Science, Medical Laboratory Science, Biotechnology, Engineering, Life Sciences, or related discipline.
• 2+ years of regulatory affairs experience for medical devices or IVDs, including regulatory submissions.
• Experience supporting CE-marking under EU IVDR and knowledge of ISO 13485, ISO 14971, ISO 20916.
• Familiarity with IVD regulatory frameworks, post-market surveillance, and vigilance requirements.
• Strong technical writing, document control, and project management skills.

Responsibilities

• Prepare and maintain IVD regulatory submission dossiers and technical documentation.
• Review labels, use statements, product claims and specifications for regulatory alignment.
• Assess analytical, clinical-performance, usability and risk-management evidence for regulatory support.
• Coordinate evidence collection with internal teams, CROs, labs, and consultants.
• Develop regulatory evidence plans and gap analyses.
• Prepare responses to regulatory authority questions and audit-related documentation.
• Maintain regulatory intelligence on applicable IVD regulations and standards.
• Support post-market regulatory activities and lifecycle changes.
• Collaborate with Quality, R&D, Clinical, Product and Commercial teams to stay compliant.

Skills

Regulatory submissions

Technical writing

Stakeholder coordination

Quality systems

IVD knowledge

Education

Bachelor degree in Regulatory Affairs or related

Job description

Mira is seeking a Regulatory Submission Specialist to lead and support the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices. The role ensures evidence across analytical, clinical-performance, and usability remains compliant through the product lifecycle.

This remote role offers collaboration with global teams and a focus on women’s health diagnostics. The ideal candidate has 2+ years in regulatory affairs for medical devices or IVDs, experience with