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Regulatory Affairs Specialist

2 semanas atrás

Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

Job Summary

Palex Portugal, a leading company in the management and distribution of innovative hospital and research solutions, is seeking a highly skilled Regulatory Affairs & Quality Assurance Specialist to join their team. As a key member of the organization, you will be responsible for ensuring compliance with regulatory requirements, managing product registrations, and providing support to various departments.

Main Responsibilities

  • Manage new product and material requests, including documentary verification, market registration, and codification.
  • Provide support to Tender and Sales departments to ensure customer requests are met, including Declaration of Conformity, Instructions for use, and Safety Data Sheets.
  • Collaborate with Competent Authorities to comply with legal and regulatory requests.
  • Maintain accurate documentation and information systems regarding marketed products in Portugal.
  • Support Qualified Person activities, including complaints and vigilance system.

Requirements

  • Degree in Science, Engineering, or similar field.
  • Minimum 3 years' experience in a similar role.
  • Experience in a multinational context (preferred).
  • Knowledge of Medical Devices and In Vitro Medical Devices legislation in Portugal.
  • Strong computer skills, including MS-Office and ERP systems.
  • Basic knowledge of quality management systems and ISO Standards.
  • Good knowledge of English and Spanish.

What We Offer

  • Integration into an expanding multinational company.
  • Collaborative and dynamic working environment.
  • Opportunities for skills development and ongoing training.
  • Competitive compensation package.