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Regulatory Engineeer FDA - Medical Devices in South of France

Employer
NonStop Consulting
Location
Nice
Salary
Negotiable
Closing date
May 18, 2019

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Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate

Job Details

In your new position, you will join the quality and regulatory affairs department and will work closely with R&D, Marketing and Industrialization departments.

Your main responsibilities will include:

  • Preparation and follow-up of PMA file and supplements of class III devices.
  • Work with the product team to develop regulatory strategies for the approval of new medical devices or their changes.
  • Determine and communicate to the teams of R & D/industrialization/Validation, regulatory requirements for the development and registration of new products, and provide the appropriate procedures
  • Handle the risk management process of the projects
  • Check the conformity of the DHF and DMR.
  • Check the technical documents related to the products changes, including changes of processes and materials.
  • Évaluer l'impact des nouvelles normes techniques et règlementations et participer à la mise en place des actions.
  • Assess the impact of the new technical standards and regulations, and participate in the implementation of the actions.
  • Ensure continuous improvement of the process in its areas of expertise
  • Support the export registration team

Skills and experience

Engineer or equivalent, and you have at least 5 years' experience in regulatory affairs related to the development of medical devices. Desired experience in preparation and follow-up of 510K (or PMA).

You must have the following skills:

  • Knowledge of American regulations (21CFR).
  • Successful experience in review and preparation of technical documents to ensure their clarity, accuracy, comprehensiveness and structure.
  • Experience in the regulatory field of product/process changes and approval process of medical devices.
  • Ability to interpret regulations on active implantable medical devices and to apply the requirements of quality systems standards such as the ISO 13485 and 21 CFR 820.
  • Successful experience in highly regulated industries such as medical devices or pharmaceuticals.
  • Understanding of the technical specifications and protocols used to test devices in accordance with international standards.
  • Ability to work actively with multidisciplinary teams.
  • Highly organized, spirit of synthesis, good editorial skills and communication
  • Fluent in English is necessary in writing and oral.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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