Remote Regulatory Submissions Specialist — EU IVDR/CE-mark

Mira; Barcelona; Remoto; EUR 60.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote work

Flexible hours

OKR-based bonus

Descrizione del lavoro

Mira is seeking a Regulatory Submission Specialist to lead and support the documentation required for in vitro diagnostic devices. You will ensure regulatory compliance across submissions and maintain evidence of analytical and clinical performance.

The role involves coordinating with internal teams, external consultants, and regulators to prepare, review, and finalize submission dossiers. This is a remote position offering flexible hours and growth opportunities.

Competenze

• 2+ years of experience in regulatory affairs for medical devices or IVDs.
• Experience preparing CE-marking documentation under EU IVDR (Reg. (EU) 2017/746).
• Knowledge of ISO 13485, ISO 14971, ISO 20916 and post-market requirements.
• Experience drafting analytical/clinical performance documentation for IVDs.

Mansioni

• Prepare and maintain IVD regulatory submission dossiers and technical documentation.
• Review labels, IFU, and product claims for regulatory alignment.
• Assess analytical and clinical evidence to support device claims.
• Coordinate evidence collection with internal teams and external consultants.
• Develop regulatory evidence plans and studies.
• Prepare responses to authority questions and audit documentation.
• Maintain regulatory intelligence for applicable IVD regulations and standards.
• Support post-market regulatory activities and lifecycle compliance.
• Collaborate with Quality, R&D, Clinical, Product, and Commercial teams.

Conoscenze

Regulatory affairs

Medical devices

IVDR

CE marking

Technical writing

Documentation

Stakeholder coordination

Regulatory submissions

Project management

Formazione

Bachelor's degree in Regulatory Affairs or life sciences

Descrizione del lavoro

Mira is seeking a Regulatory Submission Specialist to lead and support the documentation required for in vitro diagnostic devices. You will ensure regulatory compliance across submissions and maintain evidence of analytical and clinical performance.

The role involves coordinating with internal teams, external consultants, and regulators to prepare, review, and finalize submission dossiers. This is a remote position offering flexible hours and growth opportunities.