EMEA Regulatory Affairs Specialist

vor 1 Monat

Lausanne, Schweiz LHH Vollzeit

LHH Recruitment Solutions is a specialized talent recruitment boutique. We provide tailored services to help companies find the best candidates for their staffing needs.


With deep industry expertise and a commitment to excellence, LHH RS is a trusted partner in Switzerland for many years.


Our client is an international company located in Canton of Vaud.

Responsibilities :

  • Register, renew and handle the lifecycle management of products in the EMEA region;
  • Prepare responses to questions of Competent Authorities in the framework of registrations, renewals and lifecycle management;
  • Review and validate products' artworks and marketing campaigns to ensure regulatory compliance;
  • Write and review SOP, WKI, FORM for regulatory affairs-related processes;
  • Manage non-conformity process in particular the assessment of the impact on regulatory compliance of nonconformities and corrections;
  • Lead change control management by assessing substantial and non substantial change requests with their impact on regulatory compliance ;
  • Prepare PMS plan and reports related to your products managed;
  • Manage reportability of vigilance cases to the Competent Authorities, and prepare vigilance reports accordingly;
  • Act as a regulatory Subject Matter Expert during Notified Body's annual audit and lead interaction with Competent Authorities.


Profile :

  • Degree in Regulatory Affairs and/or in Life Sciences;
  • Minimum of 5 years of experience in Regulatory Affairs - related activities in life science industry, including product registration and regulatory support to product design & development projects;
  • Experience in project management as project team member;
  • Knowledge of EMEA applicable regulations especially for EU market and Middle East or LATAM markets;
  • Fluent in English.


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