Auditeur

THE COMPANY 

Join a Growing Organization Making Its Mark in France

Are you ready to be part of an exciting new chapter in the medical devices industry? This company is a well-established and respected global organization known for its expertise in quality assurance and regulatory compliance. With a reputation for excellence, they are now expanding their footprint by creating a brand-new business in France a thrilling opportunity to be part of something from the ground up.

This company is dedicated to working as a true partner with its clients, fostering relationships built on trust, expertise, and collaboration.

Their mission goes beyond compliance; they aim to empower their clients to deliver safe and innovative healthcare products to the market efficiently.

THE OPPORTUNITY 

Are you an experienced professional in the medical devices industry with a strong background in auditing? Do you thrive on ensuring quality and compliance within the healthcare sector? Join a leading Notified Body as a Lead Auditor, where your expertise will directly contribute to improving patient safety and regulatory compliance across Europe.

This is your chance to join an organization that combines global expertise with a personalized, collaborative approach, and to play a pivotal role in its exciting new venture in France. If you are passionate about quality, innovation, and making a difference, this is the perfect opportunity for you.

KEY RESPONSABILITIES

• Conduct on-site and remote audits of medical device manufacturers to assess compliance with ISO 13485, MDR, and other relevant standards.
• Perform detailed reviews of technical files to ensure alignment with regulatory requirements.
• Prepare comprehensive audit reports and provide constructive feedback to clients.
• Collaborate with cross-functional teams to ensure a high standard of client service.
• Stay updated on the latest regulatory changes and standards in the medical devices industry.

QUALIFICATIONS :

Education:

• A degree (Bachelors or Masters) in one of the following disciplines:
• Biology, Microbiology, Chemistry, Biochemistry
• Information Technology, Engineering (electrical,electronics, mechanical, materials, biomaterials,industrial sectors)
• Bioengineering, Medicine, Nursing, Dentistry, Veterinary
• Medicine
• Biomedicine, Biotechnology, Pharmacy, Pharmacology,
• Toxicology, Physics, Biophysics, or Physiology

WORK EXPERIENCE :

• Minimum 4 years of experience in the healthcare products sector or related activities.
• At least 2 years in quality management roles such as Quality Manager, Quality Assurance Specialist, Quality Management Systems Consultant, or Auditor.
• Prior experience working with or auditing for a Notified Body is required.