Join Dedalus to make healthcare safer, better and more reliable by ensuring quality and regulatory compliance as part of development project core teams
Job Summary
Join Dedalus to make healthcare safer, better and more reliable by ensuring quality and regulatory compliance as part of development project core teams.
You will be responsible for regulatory plans, strategies, process adherence, and facilitating compliance during inspections and audits.
Dedalus fosters a diverse and inclusive culture encouraging learning, innovation, and making a meaningful difference for millions of patients worldwide.
Matching Summary
Join Dedalus to make healthcare safer, better and more reliable by ensuring quality and regulatory compliance as part of development project core teams.
Skills & Requirements
Must-have
Regulatory compliance for medical devices
Risk management principles application
Regulatory submission documentation
Design control process facilitation
Internal and external audit performance
English and French professional proficiency
Nice-to-have
Knowledge of GDPR and ISO 27001
Experience with QMS tools
Independent work towards deadlines
Strong problem solving skills
Excellent communication and interpersonal skills
Key Requirements
Subject matter expert in regulatory affairs
In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366
Familiarity with Medical Device Directive, MDR, IVDR
Experience with CAPA/NC regulations
Professional level English and French
Knowledge of medical device classification and submission regulations