● Assures and monitors the company’s compliance with relevant quality and regulatory norms,
directives and regulations for geographical areas including EU and US.
● Coordinates and manages the company’s quality assurance system, specifically ISO's
● Plans, organizes and implements internal and external audits and maintains internal audit
schedules and records including tracking CAPA activities as required
● Develops and maintains the regulatory knowledge of all European regulations and FDA
regulations where applicable.
● Develops quality assurance plans by conducting risk analyses; identifies critical control points
and preventive measures; establishes critical limits; monitors procedures, corrective actions,
and verification procedures.
● Monitors and ensures that all regulatory expenses remain within the given budget.
● Manages quality issues and interacts with R&D team and products suppliers regarding these.
● Reviews and investigates customer complaints, determines product failure root causes and
evaluates risk of failures.
● Ensures that the quality system is understood and applied throughout the organisation on all
levels by personnel concerned.
● Authorises product release to stock and completion of relevant records upon receipt.
● Handles detailed, complex concepts and problems, balances multiple tasks simultaneously,
and makes rapid decisions regarding administrative issues.
● Establishes professional relationships with Management, employees, suppliers, Notified
Body(ies) and Competent Authority(ies).
● Plans and meets deadlines. Maintains a flexible work schedule; hours may be long and
● Expected 30% of time to travel national and international
● Minimum of 3 years in Quality and Regulatory Compliance function or equivalent experience.
● B.Sc. in Science, Engineering, Engineering management, or related discipline
● Experience with ISO13485 and FDA 21CFR 820. a +
● Regulatory knowledge and experience with IVD medical devices and reagents. Experience
with FDA and EU Notified Bodies is a plus.
● Ability to manage complex projects and timelines in a matrix team environment.
● Strong oral and written communication and presentation skills.
● Ability to independently identify compliance risks and escalate when necessary.
● Ability to lead and coach others.
● Knowledge of office suites softwares, with an ability to learn other computer based systems
● Fluent in English and French.