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Quality & Regulatory Manager

Plný úvazek
Villejuif
Plat: Neuvedeno
Počáteční datum: 01. dubna 2019
Žádná práce na dálku
zkušenosti: > 10 let
Vzdělání: Magisterský stupeň vzdělání

Stilla Technologies
Stilla Technologies

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Popis pozice

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

  • Define and maintain Stilla’s Quality Policies and Quality Manual in collaboration with the Management
  • Identify and prioritize actions to put in place a QMS, more particularly:
    • Design processes structure and key performance indicators with identified pilots
    • Organize and optimizin document management, non-conformities and CAPAs
    • Record and coordinate the resolution of quality issues (complaints, non-conformities) with CAPAs follow-up
    • Plan, perform and coordinate internal audits (including suppliers’) as well as external audits (from customers, notified bodies or regulatory authorities)
    • Ensure regulatory and standards watch
    • Evaluate suppliers in collaboration with Purchasing and R&D department
    • Prepare and coordinate the management review of the QMS
  • Make all existing processes, methods and tools compliant
  • Coordinate and train teams to put in place and comply with the QMS
  • Monitor and report progresses

2. Ensure regulatory approval for the Naica system

  • Coordinate with external partners for quality and regulatory assurance
  • Provide expertise and training to the teams regarding the regulatory requirements
  • Participate in the definition of product intended use, positioning and claims from RUO to IVD, and ensure its consistency with product risk analysis
  • Put in place Product Life Cycle management tools and Change Management tools
  • Coordinate and train teams to perform product risk analysis including change control
  • Source and manage external partners to help certify the Naica system
  • Negotiate quality agreements with key suppliers
  • Prepare and collect all documents required for CE-IVD certification of instruments, consumables, software and assays/kits
  • Maintain technical documentation to regulatory and standards state-of-the-art, as well as change management

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,


Požadavky na pozici

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

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