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Regulatory Affairs Specialist

Il y a 2 mois


SalondeProvence, Provence-Alpes-Côte d'Azur, France Biotech Dental Temps plein
About Us

French manufacturer of medical devices and digital solutions for dentists and dental laboratories, Biotech Dental is committed to innovation and excellence. Our mission is to provide high-quality care at an affordable price.

Our values are human-centered, innovative, and made in France.

As a global leader in the dental industry, we are also committed to sustainability and social responsibility. We strive to improve access to dental care for those in need and promote a culture of environmental responsibility.

Our purpose is to create a world of smiles.

Job Description

As a Regulatory Affairs Specialist, you will be responsible for:

  • Developing and updating technical dossiers for new products under EU Regulation 2017/745

  • Preparing and updating Quality Management System documents in collaboration with the Regulatory Affairs team

  • Providing regulatory expertise on new product development projects and modifications to existing products

  • Managing product distribution files

  • Participating in post-market surveillance activities

  • Validating marketing materials (labels, instructions, brochures, advertisements)

  • Managing international product registrations, including the US

  • Staying up-to-date with regulatory and normative requirements

  • Improving working methods and tools within the team

Requirements
  • Bachelor's degree or higher in a relevant field (quality or regulatory affairs for medical devices)

  • Proficiency in English, particularly in writing

  • Strong writing skills and knowledge of EU Regulation 2017/745 and ISO 13485