Regulatory Affairs
2 semanas atrás
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United States
REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALISTTN Portugal
EUR 30,000 - 40,000
Be among the first applicants.
4 days ago
Client:LusoPalex
Location:Portugal
Job Category:Other
EU work permit required:Yes
Job Reference:5f0677b7cb46
Job Views:4
Posted:14.02.2025
Expiry Date:31.03.2025
Job Description:Palex Portugal, a leading company in the management and distribution of innovative hospital and research solutions, is recruiting a Regulatory Affairs & Quality Assurance Specialist.
Main Responsibilities: Ensures correct management and approval of new products and materials requests upon documentary verification, including but not limited to: Declaration of Conformity/ EC Certificate, Instructions for use and labelling, and other applicable documentation.Ensures proper market registration and codification of the new products and materials in Portugal and also renews and keeps up-to-date current registrations and codifications, following the procedures established by the Competent Authorities and adopted by the Company.Provides support to the Tender and Sales departments to comply with customer's requests, including but not limited to: Declaration of Conformity/ EC Certificate, Instructions for use and labelling, Lot Certificates and Safety Data Sheets.Provides support to Competent Authority to comply with legal and regulatory requests.Ensures correct upload and maintenance up-to-date in the Information Systems of the Company, regarding the documented information of the products marketed in Portugal.Assures correct back-up of the activities of the Qualified Person, when necessary, including activities related to complaints and the vigilance system.Ensures compliance with company Code of Ethics.Other duties as requested, including, but not limited to participating in special Projects related with regulatory/legislative demands.Knowledge & Experience: Degree in Science, Engineering or similar.Minimum of 3 years' experience in a similar role.Experience in a multinational context (preferred).Knowledge of Medical Devices and In Vitro Medical Devices legislation and product requirements in Portugal, in particular, knowledge of product registration process in Infarmed.Strong computer skills including MS-Office and ERP systems (preferably SAP).Basic knowledge of quality management systems and ISO Standards (9001, 14001).Good knowledge of English (preferred) and Spanish.Awareness of the requirements of relevant local and EU regulations.Skills & Capabilities: Strong willingness to comply with regulations and procedures.Teamwork and collaboration.Critical thinking.Flexibility and adaptability to a fast-changing environment.What we offer: Integration into an expanding multinational company.Collaborative and dynamic working environment.Opportunities for skills development and ongoing training.Basic salary + Meal allowance + Variable bonus according to performance.Social benefits in force in the company: Health Insurance, Life Insurance, among others.
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