Stilla is hiring a Quality & Regulatory Manager to drive the transition of the company toward the clinical market.
The Quality & Regulatory Manager ensures Stilla’s transition toward the clinical market. He/she drives the implementation of the Quality Management System and coordinates with external partners for regulatory compliance. He/she is responsible for the certification of the Naica system for diagnostic use in Europe, the USA, and Asia.
1. Put in place a Quality Management System compliant with ISO 13485
2. Ensure regulatory approval for the Naica system
Why join us?
• Drive the company toward the clinical market and derisk its operations in a challenging environment!
• Join a young and dynamic Life Science company growing at a 3-digit pace!
• Work with a team who shares a passion for building successful Life Science Products based on deep technological innovations.
Location:
Main office: Paris
This position involves physical activity such as travel
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion,
Our ideal candidate:
• Has 10+ years of experience in an industry with strong regulatory constraints, ideally in IVD
• Has one or more successful experiences implementing Quality Management Systems (QMS) compliant with ISO 13485 and compatible with continuous improvement of products and processes
• Has ideally built a QMS from scratch
• Has a deep knowledge of ISO 14971, Directive 98/79/EC and/or Directive 93/42/EEC, including the imminent regulatory changes (Regulation 2017/746) and ideally their equivalent FDA standards
• Has one or more successful experiences getting products CE-IVD certified and/or FDA cleared and/or China-FDA cleared
• Has successful experiences negotiating Quality Agreements with key suppliers
• Has experience managing and coordinating teams
• Must speak French and English fluently
Tyto společnosti rovněž nabírají pracovníky na pozici "{profese}".