Job Summary

Responsible for site-specific aspects of the Quality Management System to ensure the company meets and maintains all applicable quality and regulatory compliance requirements.

Main duties and responsibilities

• Manage the requirements for quality and regulatory compliance for the manufacture, sale and global distribution of diagnostic products.
• Support for regulatory and customer audits.
• Managing the company's key supplier base from a quality perspective.
• Support and develop data for input into the site management reviews.
• Provide quality and regulatory support to development and OEM projects, including the generation review and approval of process validation documentation.
• Review and approval of technical, regulatory and QMS documentation.
• Assist in regulatory submissions for existing and new products.
• Support compliance of the company's Risk Files in accordance with ISO 14971.
• Assist where required in process and product compliance to assure GMP is maintained for IVD manufacture.
• Maintain the site complaint investigation and vigilance reporting processes, and co-ordinate site PMS activities.
• Site responsibility for the Q-Pulse system.
• Ensure Executive Team (through the HQARC) are advised on any quality or regulatory changes that will impact the Paris business.

Qualifications and experience required

• Must be fluent in both verbal and written English and French.
• Should be fully conversant with key regulations for In-vitro Diagnostic Devices.
• Experienced and conversant with current requirements for ISO 9001, ISO 13485 (including CMDCAS), 21 CFR Part 820.
• Qualified internal auditor to ISO 13485.
• Experience managing suppliers from a quality perspective.
• Previous experience in conducting process validation studies.
• Experience in the testing and validation of software would be a distinct advantage.
• Job Type: Contract

Required experience

• ISO 9001, ISO 13485 21CFR Part 820: 1 year
• In-vitro Diagnostic Devices: 1 year

Required language

Fluent French