Remote Regulatory Submission Lead – EU IVDR/CE for IVDs

Mira; Lombardia; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Fully remote

Flexible hours

OKR-based bonus

Career growth opportunities

Job summary

Mira, a San Francisco-based hormonal health company, seeks a Regulatory Submission Specialist to lead regulatory documentation for IVD devices. You will ensure evidence supports claims, align labeling, and coordinate with internal teams and external consultants to maintain compliance throughout the product lifecycle.

The role requires EU IVDR experience, strong technical writing, and the ability to work in a fast-paced startup while collaborating across global teams.

Qualifications

• 2+ years of regulatory affairs experience for medical devices or IVDs
• Excellent technical writing and document-control skills
• Strong project-management and stakeholder coordination abilities
• Ability to work independently in a fast-paced startup environment

Responsibilities

• Prepare, compile, maintain IVD regulatory submission dossiers and technical docs
• Review intended-use statements, labeling, and product specs for regulatory alignment
• Assess analytical, clinical, usability, risk-management evidence to support claims
• Coordinate evidence collection with internal teams, CROs, labs, and consultants
• Identify evidence gaps and develop regulatory evidence plans
• Support preparation of clinical-performance documentation and evaluations
• Prepare responses to regulatory authority requests and audits
• Maintain regulatory intelligence on IVD rules, standards and market needs
• Support post-market activities including vigilance and recalls
• Collaborate with Quality, R&D, Clinical, Product and Commercial teams

Job description

Mira, a San Francisco-based hormonal health company, seeks a Regulatory Submission Specialist to lead regulatory documentation for IVD devices. You will ensure evidence supports claims, align labeling, and coordinate with internal teams and external consultants to maintain compliance throughout the product lifecycle.

The role requires EU IVDR experience, strong technical writing, and the ability to work in a fast-paced startup while collaborating across global teams.