Regulatory Affairs Specialist

2 mesi fa


Pomezia, Lazio, Italia STERIS A tempo pieno

Job Title: Regulatory Affairs Specialist

Job Category: Regulatory Affairs

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at STERIS. As a key member of our Regulatory Affairs function, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements in the European Union and other international markets.

Responsibilities:

  • Develop and maintain a thorough understanding of regulatory requirements and standards, including the European Union's Medical Device Directive and Regulation, as well as international standards such as ISO 13485 and ISO 14971.
  • Support the preparation, monitoring, and maintenance of documents for submissions to regulatory authorities and shared drive folders, and databases in an accurate, complete, and timely manner.
  • Assist in the preparation, compilation, and submission of regulatory documents for the registration of current and new products in various markets.
  • Monitor and maintain regulatory documents to ensure the CE marking of our products.
  • Support local commercial and tender offices with RA documentation and information.
  • Interact with regulatory authorities, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate.

Requirements:

  • High School Diploma or Bachelor's Degree in Engineering, General, or Biology.
  • Excellent PC skills, including Microsoft Office applications.
  • Italian mother tongue and English fluent are mandatory.

Competencies:

  • Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action.
  • Self-starter that is highly organized.
  • Strong oral and written communication skills.

About STERIS:

STERIS is a leading provider of infection prevention and surgical solutions. We help our customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.



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