
Advanced Regulatory Affairs Specialist
ResMed
full-time
Posted on:
Location Type: Hybrid
Location: Vimercate • Italy
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Job Level
About the role
- participate to all regulatory activities related to the import and distribution of ResMed products in EMEA region
- collaborate to the evaluation of regulatory requirements
- preparation, planning, submission, archiving and maintenance of product registrations
- interact with local regulatory partners and legal manufacturers
- support regulatory requests from the field
- contribute to the implementation of global or regional regulatory tools
Requirements
- Bachelor's Degree of Science or Engineering
- first experience in Regulatory Affairs positions in a similarly regulated medical industry
- Knowledge of Medical device regulatory framework
- Fluent in English (read/spoken/written)
Benefits
- bonus plan based on position
- Working from home flexibility
- referral bonus
- ResMed's preferred shareholding programme
- internal career opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory requirements evaluationproduct registration preparationsubmission and archivingregulatory requests supportregulatory tools implementation
Soft skills
collaborationcommunicationinterpersonal skills
Certifications
Bachelor's Degree in ScienceBachelor's Degree in Engineering