EMEA Regulatory Affairs Specialist (m/f)

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.

Permanent Contract #LI-Hybrid

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