Head of Quality and Regulatory Affairs
Vor 2 Tagen
Xsensio is a Swiss start-up company developing the Lab-on-SkinTM sensing platform to sense in real-time biochemical information at the surface of the skin, providing unprecedented real-time information about our health and wellness, in a simple and mínimally invasive way.
To strengthen our team (EPFL Innovation Park, Lausanne, Switzerland), we are looking for a **Head of Quality and Regulatory Affairs** (XS21-B-03).**
**Roles and Responsibilities**:
As Head of Quality and Regulatory Affairs in a fast-paced cross-functional team, you will oversee all aspects related to quality and regulatory affairs to plan for the market launch of medical devices. You will play a hands-on role on the team, and focus on:
- Developing a regulatory strategy for our product pipeline in conjunction with the company management and the R&D and product development teams, and overseeing its implementation on multiple markets.
- Selecting, implementing and maintaining quality system processes, in compliance with Quality System Regulation. Managing all aspects of regulatory compliance with the FDA, Swiss Medic and EU notified bodies.
- Organizing clinical studies activities together with scientific experts, in accordance with ethics regulations.
**Requirements**:
- Master’s or PhD degree in bioengineering, medicine or life sciences, with 5+ years of experience in a similar managerial position in the medical device industry (preferably with class II devices).
- Experience successfully implementing a medical quality system.
- Experience interacting with Regulatory Authorities and Notified Bodies, with a detailed understanding of the EU, Swiss and USA medical device regulations.
- Experience successfully launching a medical device on the market a plus.
- Experience in project management.
- Strong interpersonal skills, ability to work independently and take initiatives. Excellent verbal and written communication skills.
- Fluency in English; proficiency in French a plus.
- Swiss or EU/EFTA work permit.
Xsensio is an equal opportunity employer: we celebrate diversity and are committed to creating an inclusive environment for all employees.
No recruiters or agencies please.
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