Senior Associate - Regulatory Affairs (EU MDR)
ClinChoice(4 days ago)
About this role
A Regulatory Affairs Specialist supporting maintenance and resubmission of medical device technical files and design dossiers under EU MDR (2017/745). The role ensures regulatory compliance, documentation readiness, and coordination with project teams and affiliates throughout the submission process.
Required Skills
- EU MDR
- ISO13485
- FDA Regulations
- Document Management
- Quality Control
- PLM
- Adobe PDF
- Microsoft Office
- Cross-Functional Collaboration
- Communication
Qualifications
- Bachelor's Degree (Life Sciences Preferred)
About ClinChoice
clinchoice.comClinChoice is a full‑service global contract research organization (CRO) that helps accelerate drug and medical device approvals to market. They offer end‑to‑end clinical development, regulatory strategy, and operational support across study design, execution, data management and safety to guide sponsors through all phases of development. With global site networks, therapeutic expertise and data‑driven processes, ClinChoice aims to shorten timelines and reduce risk for development programs. They partner with biotech, pharma and device companies to navigate complex regulatory pathways and bring safer products to patients.
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