Regulatory Affairs Specialist

1 settimana fa


Pomezia, Lazio, Italia STERIS A tempo pieno

Job Summary

STERIS is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will play a critical role in supporting the implementation of efficient and effective processes to obtain and maintain clearance to market STERIS products globally.

Key Responsibilities

  • Develop a working knowledge of regulatory requirements and standards associated with medical devices, including the European Union's Medical Device Directive and the EU MDR Regulation.
  • Support the preparation, monitoring, and maintenance of documents for submissions to regulatory agencies and shared drive folders.
  • Assist in the preparation, compilation, and submission of regulatory documents for product registration in various markets.
  • Monitor and maintain regulatory documents to ensure CE marking compliance.
  • Interact with regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate.

Requirements

  • High School Diploma or GED; Bachelor's Degree in Engineering or Biology preferred.
  • Excellent PC skills, including Microsoft Office applications.
  • Italian mother tongue and English fluency required.

Competencies

  • Strong interpersonal skills and ability to work effectively with external stakeholders.
  • Self-starter with high organizational skills.
  • Strong oral and written communication skills.


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