Senior IVD Regulatory Submissions Lead - Remote

Mira; San Francisco (CA); Hybrid; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Fully remote

Competitive salary

Bonus program

Career growth

Job summary

Mira is hiring a Senior Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. The role ensures clinical, analytical, usability, risk-management, and labeling evidence is compiled into submission-ready documentation and supports compliance across the product lifecycle.

This remote UK-based position emphasizes experience with CE-marking under EU IVDR and international IVD standards, with opportunities to collaborate across Quality, R&D,

Qualifications

• Experience leading regulatory submissions for IVD devices.
• Proven ability to compile technical documentation and performance evidence.
• Working knowledge of EU IVDR and post-market requirements.
• Excellent writing, project management, and stakeholder coordination.

Responsibilities

• Prepare, compile, and maintain regulatory dossiers and technical docs.
• Review labeling, instructions for use, and product claims for compliance.
• Assess analytical, clinical-performance, usability and risk data to support claims.
• Coordinate evidence collection across internal teams and external consultants.
• Develop regulatory evidence plans and respond to regulator queries.
• Maintain regulatory intelligence on applicable standards and market needs.
• Support post-market activities and lifecycle regulatory updates.
• Collaborate with Quality, R&D, Clinical, Product, and Commercial teams.

Skills

Regulatory submissions

Technical documentation

Clinical-performance evidence

International IVD regulatory

Education

Bachelor's degree in Regulatory Affairs or related field

Job description

Mira is hiring a Senior Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. The role ensures clinical, analytical, usability, risk-management, and labeling evidence is compiled into submission-ready documentation and supports compliance across the product lifecycle.

This remote UK-based position emphasizes experience with CE-marking under EU IVDR and international IVD standards, with opportunities to collaborate across Quality, R&D,