Quick Overview
Job Description
Must-Have Qualifications
Bachelor’s degree or equivalent experience in Engineering, Physical/Biological Science, or another technical field.
2–3+ years of compliance experience within the medical device industry.
Working knowledge of project management tools and techniques.
Knowledge of:
EU MDR
ISO 13485:2016
MDSAP
21 CFR Part 820
Health Canada requirements
Other applicable international regulatory requirements
Experience interpreting regulations and providing guidance related to a Quality Management System (QMS).
Demonstrated experience working with cross-functional and cross-plant project teams.
Strong organizational, written, and verbal communication skills.
Ability to prioritize multiple tasks effectively in a deadline-driven environment.
Strong interpersonal skills with the ability to work with stakeholders at all organizational levels.
Ability to facilitate and support corrective action/CAPA implementation.
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