Remote EU IVDR/CE Regulatory Submissions Specialist

Mira; Dublin; Remote; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Fully remote

Career growth

Competitive salary

Flexible hours

Job summary

Mira seeks a Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. You will ensure evidence across analytical, clinical, usability, risk, and labeling meets submission requirements.

Ideal candidates have experience with regulatory submissions and international IVD requirements, and can collaborate with Quality, R&D, Clinical, Product, and Commercial teams in a fast-paced startup environment.

Qualifications

• Bachelor's degree in regulatory affairs or life sciences.
• 2+ years in regulatory affairs for medical devices or IVDs.
• Experience with EU IVDR CE-marking documentation.
• Knowledge of ISO 13485 and ISO 14971.

Responsibilities

• Prepare and maintain IVD regulatory submission dossiers.
• Review intended-use statements, labels, and product specs for regulatory alignment.
• Assess analytical/clinical evidence to support claims.
• Coordinate evidence collection across internal and external teams.
• Support post-market regulatory activities and vigilance reporting.
• Maintain regulatory intelligence on standards and market requirements.

Skills

Technical writing

Regulatory submissions

Project management

Stakeholder coordination

Independent work

Education

Bachelor's degree in Regulatory Affairs or life sciences

Job description

Mira seeks a Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. You will ensure evidence across analytical, clinical, usability, risk, and labeling meets submission requirements.

Ideal candidates have experience with regulatory submissions and international IVD requirements, and can collaborate with Quality, R&D, Clinical, Product, and Commercial teams in a fast-paced startup environment.