Compliance Analyst 3 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.