Quality And Regulatory Affairs

hace 4 días


Barcelona, España Werfenlife Sa. A tiempo completo

Quality and Regulatory Affairs (QA/RA) TraineeThe Quality and Regulatory Affairs (QA/RA) Trainee supports the execution of preand/or post market regulatory affairs departmental functions, including, but not limited to,assisting in the preparation of documentation and information required to place and tokeep products on the market: regulatory submissions, licensing and registrations,assisting in the execution of post market surveillance activities: complaint evaluations,product corrections, removals and recalls.Key AccountabilitiesAssists in efforts to ensure the company is properly registered and in compliancewith applicable national and international regulations.Collaborates in efforts to prepare and submit regulatory submittals for marketclearance, licensing, registration and legalization.Supports the execution of global field corrective actions/recalls.Assists in interactions regarding regulatory affairs with all functional areas of thecompany as required, including senior management, mainly, providing support to theTender and Sales departments to comply with customer's requests, including but notlimited to: Declarations of Conformity/EC Certificates, Instructions for Use andLabelling, Lot Certificates and Safety Data Sheets.Ensures correct upload and maintenance up to date in the Information Systems ofthe Company, regarding the documented information of the tasks under his/herresponsibility.Ensures compliance with Werfen Code of Ethics.Networking/Key relationshipsThis position may require cooperating with the Tender Office, Sales and MarketingOffice, Service Office, Supply Chain Office, Regulatory contact of representedcompanies/manufacturers and customer contacts.Minimum Knowledge & Experience required for the positionEducation: Degree in a science, finance and administration discipline or equivalentExperience: Not required.Additional Skills/Knowledge:o Awareness of the requirements of relevant local and international regulations.o Strong computer skills required: MS Office, ability to use an enterpriseresource planning system (ERP) and other regulatory software tools.o Language: Spanish and English.Skills & CapabilitiesThe ideal candidate for this position will exhibit the following skills ando Strong willingness to comply with regulations and procedureso Excellent written and verbal communication skillso Teamwork and collaborationo Delivers resultso Relationship managemento Flexibility and adaptability to a fast-changing environment Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a... Overview Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide... #J-18808-Ljbffr



  • Barcelona, Barcelona, España Werfenlife Sa. A tiempo completo

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