Our client is a swiss innovative medical device company developing and manufacturing a
breakthrough imaging solution with the potential to improve patient care and cancer surgery
Offering real-time ability to identify cancerous tissues and react immediately, this new
visualization modality holds the promise for a broad range of surgical and diagnostic applications.
As Regulatory/Quality Assurance Specialist, you will report to the CTO and will be responsible for
establishing and maintaining the company’s quality assurance system and for ensuring its regulatory
Essential Function and Responsibilities
- 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 13485
and FDA 21CFR 820.
- Develops post-market surveillance plans and manages post-market surveillance and vigilance activities.
- 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.
- 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.
- 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 software, with an ability to learn other computer-based systems
- Fluent in English and French.