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Regulatory Affairs Specialist

2 semanas atrás

Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

Job Summary
Palex Portugal is seeking a highly skilled Regulatory Affairs Specialist to ensure compliance with regulations and procedures related to medical devices and in vitro diagnostic products. The successful candidate will work closely with the Tender and Sales departments to provide support in obtaining necessary documentation, such as Declaration of Conformity/ EC Certificate, Instructions for use and labelling, Lot Certificates, and Safety Data Sheets.

Main Responsibilities

  • Ensure correct management and approval of new products and materials requests upon documentary verification
  • Properly register and maintain market registrations and codifications of new products and materials
  • Support the Tender and Sales departments in complying with customer requests
  • Collaborate with Competent Authorities to comply with legal and regulatory requests

Knowledge and Experience

  • Degree in Science, Engineering, or similar field
  • Minimum 3 years' experience in a similar role
  • Experience in a multinational context (preferable)
  • Knowledge of Medical Devices and In Vitro Medical Devices legislation and product requirements in Portugal
  • Strong computer skills, including MS-Office and ERP systems (preferably SAP)

We Offer

  • Integration into an expanding multinational company
  • Collaborative and dynamic working environment
  • Opportunities for skills development and ongoing training
  • Benefits, including health insurance and life insurance