Critères de l'offre
Métiers :
- Regulatory Affairs Assistant
Expérience min :
- 3 à 5 ans
Diplômes :
- No Diploma
Compétences :
- English
- Regulations
Lieux :
- Lausanne
Conditions :
- Permanent contract
- Full Time
L'entreprise : LHH
The Adecco Group Switzerland
Description du poste
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.
Référence : 89A6D718-DAA2-42B7-9A7A-0C0C13B8513C