Experience:
3-8 years in Medical Device Industry with direct experience in Design Controls, Technical Documentation, DHF Management, Regulatory Documentation, or Quality Systems. Experience in cardiovascular medical devices and international regulatory submissions will be preferred.
Required Skills & Experience
Technical Writing & Documentation Management
Design History File (DHF) Preparation
Device Master Record (DMR) Management
Technical Documentation & Design Dossiers
Risk Management Documentation (ISO 14971)
Regulatory Documentation & Product Registration Support
Design Control Requirements
Change Control (ECR/ECO)
CAPA Systems Knowledge
Traceability Matrix Development
Quality Management System Documentation
Strong Communication & Cross-functional Collaboration
MS Office & Document Control Systems Proficiency
Regulatory Documentation
Traceability Management
Root Cause Analysis
Quality Systems Compliance
Behavioural:
Robust Attention to Detail
Excellent Communication Skills
Analytical Thinking
Problem Solving
Team Collaboration
Planning and Organization
Accountability
Continuous Improvement Mindset
Qualifications and Experience:
Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline.
Master’s degree in quality assurance, Regulatory Affairs, or related field preferred.
3 to 5 years of experience in regulated medical device environments.
Experience supporting product development from concept through commercialization.
Experience with ISO 13485, ISO 14971, EU MDR 2017/745, Design Controls, Technical Documentation, CAPA Systems, and Change Control processes.
Experience supporting international regulatory submissions preferred.