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Ingénieur Affaires Réglementaires (Dispositifs Médicaux) H/F

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Requisition Number EMEA09253

Location Montpellier

Job Summary

Reporting to the Group Regulatory Affairs Director and workingclosely with other team members and departments, the RegulatoryAffairs Engineer will implement the necessary actions to ensure thesite’s compliance with NF EN ISO 13485, CFR 21 Part 820, 806, Sors98-282, Directive 93/42/EEC, MDR 2017/745, CFDA and any otherstandards deemed necessary for the company’s development.

Principal Duties and Responsibilities

  • Respect the Group’s values
  • Ensure product compliancewith the standards applicable in the markets where the product issold
  • To manage the processes for the marketing of devices,registrations and their maintenance
  • Manage productregistration processes in the different countries and ensure theirrenewal according to commercial needs
  • Review proposedproduct changes to assess their impact on the regulatory status ofproducts and ensure continued compliance with applicablestandards
  • Organize regulatory monitoring
  • Manage theprocess of reporting changes to the relevant bodies
  • Interpret and apply current regulations and standards to companypractices and ensure appropriate dissemination of information
  • Inform the project development teams about the regulations,their evolution and ensure their application
  • Maintain thetechnical file for CE marking and the design history file inconjunction with the R&D and production departments
  • Participate in the marketing/regulatory strategy for theplanning of the product launch
  • Participate in developmentprojects as an RA representative
  • To authorize the releaseof products if necessary by checking the adequacy between theregulatory status of the products and their destination
  • Ensure regular reporting to the Group Regulatory AffairsDirector

Expected Areas of Competence

  • Knowledge of DM ISO 13485, DM 93/42, GMP, FDA
  • Knowledge of the 60601-1, 62304 standard
  • Practice of audit techniques
  • Rigour and autonomy
  • Good written and oral communication
  • Diplomacy and contact skills
  • Professional written and spoken English
  • General knowledge of the main technologies (software, mechanical)applied to medical devices
  • In-depth knowledge of quality tools and methods
  • Critical thinking, listening skills, good analytical skills andstrong qualities of rigour and method
  • Ability to impose the applicable procedures in force, and todemonstrate a certain pedagogical sense
  • Ability to work in a team and project management mode

Education/Experience Requirements

The Regulatory Affairs Engineer has an engineeringbackground or equivalent university education. Prior to joining thecompany, the Regulatory Affairs Engineer may have experience inimplementing and leading Quality Management Systems in the medicaldevice industry or in a highly regulated environment.

  • 3 to 5 years professional experience in a Quality / Controloperational function in the medical device industry or other regulated environment
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