Regulatory Affairs Specialist

Il y a 2 mois

Marseille, France Talents Solutions Temps plein

Title : Regulatory Affairs Specialist 
Location: Marseille, France 

Are you looking for a new challenge? Would you like to work with innovative devices? If your answers are YES keep reading

A French MedTech organization specializing in innovative, minimally invasive implants aimed at restoring essential physiological functions for the treatment of cardiac diseases and urinary incontinence, is seeking a Regulatory Affairs Specialist to join their team.

The opportunity:

This will be the chance for you to contribute to the development of innovative products development and playing a pivotal role in bringing cutting-edge solutions to market, impacting millions of lives.
You will have the opportunity to be integrated into an innovative program within the rigorous field of cardiac surgery.
This position will let you work accros their two sites in France and another one in Italy.
You will join a dynamic and motivated team where you will continuous learn opportunities through available training programs.


Responsibilities:

  • Coordinate the regulatory and normative process to integrate requirements across all necessary levels of the organization.
  • Establish regulatory strategy based on targeted markets.
  • Support clinical investigation processes, particularly in drafting Investigator Brochures for submission to authorities and ethics committees.
  • Prepare regulatory dossiers and implement evaluation procedures with authorities.
  • Manage documentation development and ensure administrative registration procedures.
  • Contribute to clinical evaluation processes in collaboration with clinical services.
  • Oversee post-market surveillance and periodic reporting.
  • Manage vigilance processes, including reporting and communication with authorities.
  • Correspond with regulatory agencies, particularly the ANSM, in collaboration with the Regulatory Affairs Director.
  • Provide support to R&D by reviewing project deliverables.
  • Monitor regulatory processes within the QMS and update site regulatory procedures.
  • Support process validation activities related to regulatory requirements.
  • Assist in reimbursement dossier preparation.

Requirements:

  • Minimum 3 years of regulatory experience in implantable medical devices (Class IIb or III).
  • Excellent written and verbal English communication skills.
  • Experience in regulatory dossier creation and CE marking is a plus.

If you are interested in this position, please submit your application to monia@talentssolutions.fr.

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