Regulatory affairs Specialist F/M

France - Ile de France

Fonction Affaires réglementaires
Secteur Industrie
Region / Pays Ile de france
Référence de l'offre RA
Lieu Clamart
Information sur la société

LivaNova is a global medical device company and a leader in the treatment of cardiovascular diseases.

The Company develops, manufactures and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders.

Within the CRM Franchise  the Regulatory Affairs (RA) Specialist  is primarily responsible with all aspects of pre-market regulatory affairs for  a dedicated product of Livanova CRM, in order to obtain device pre-market approval in the European Community (EC), the United States of America (USA), Japan Canada and Australia.

Description du poste

Reporting to Regulatory Affairs Manager, the incumbent will:

  • Participate on project teams for purposes by identifying regulatory requirements for market clearance or clinical trials and review documents anticipated as key components of subsequent pre-market approval regulatory applications.
  • Develop regulatory submission applications for introduction of new or modified devices, new or expanded indications for use or changes to the manufacturing/quality processes.
  • Write summary technical reports for regulatory submissions
  • Respond to registration requests from regulatory authorities
  • Monitor the pre-market approval process to achieve expected product approval dates.
  • Maintain regulatory files to ensure the Company’s compliance with regulatory requirements.
  • Other general responsibilities:

  • Establish and maintain good working relationships with Product development, marketing, operations, quality assurance and clinical research personnel involved in the product development projects
  • Be the Franchise contact point for any regulatory question regarding his/her area
  • Contribute to the regulatory watch in his/her area.
  • Write and maintain files of all regulatory correspondence with all agencies.
  • Identify and communicate emerging regulatory issues likely to impact the submission of specific reports and studies.
  • Comply with all established company policies and procedures, objectives, quality assurance program, safety and environmental standards.
  • Perform other related duties as directed by the RA Manager / Senior Management or as required in support of company‘s objectives.
Profil du candidat

Education

  • Biomedical Engineering degree with mechanics and/or electronics background

 

Experience

  • Beginner or with a first experience in Regulatory Affairs (3-5 years experience in Regulatory Affairs)

 

Knowledge and Skills

  • Fluent in English (both writing and speaking)
  • Teamwork, communication, and ability to co-ordinate multidisciplinary groups
  • Agile, sharp, synthetic
  • Ability to summarise while adapting to the reader’s profile
  • Ability to set priorities

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