Regulatory Specialist

3 settimane fa


Bologna, Emilia-Romagna, Italia Silicon Biosystems A tempo pieno

Job Summary

We are seeking a highly skilled Quality Assurance and Regulatory Specialist to join our team at Silicon Biosystems S.p.A. in a challenging role that will ensure our medical devices meet current regulatory requirements.

The ideal candidate will have a strong background in quality assurance and regulatory affairs, with experience in working with R&D, QC, manufacturing, and other departments to ensure product compliance.

Key Responsibilities

The Quality Assurance and Regulatory Specialist will be responsible for:

  • Supporting and collaborating with R&D to apply the Design & Development process to our products
  • Managing design change control processes
  • Participating in risk management processes and supporting the preparation of risk analyses
  • SUPPORTING THE DHF PREPARATION
  • Ensuring the correct transfer of products from design phase to production phase, ensuring production sites have correct specifications, procedures, and work instructions
  • Preparing and maintaining technical files and technical documentation according to the Machinery Directive 2006/42/EC, Regulation 2017/746, and all other applicable laws and standards
  • Preparing and maintaining product documents, such as labelling, instruction for use, and manuals
  • Drafting quality assurance procedures
  • Implementing applicable standards
  • Managing CAPA (Corrective Action Preventive Action)

Requirements

To be successful in this role, you will need:

  • A degree in Biology, Chemical, Biomedical Engineering, Electronical Engineering, or equivalent degrees
  • Excellent English knowledge (written and spoken)
  • 2-5 years of experience in Quality Assurance and/or Regulatory Affairs or Research & Development or Verification & Validation in a company of Medical Devices, preferably In Vitro Medical Devices
  • Experience with Quality Management Systems and ISO 13485, ISO 14971
  • Ability to lead projects in dynamic environments
  • Ability to work in a collaborative and multidisciplinary environment, with accuracy, reactivity, and reliability, and with great attention to details

About Us

Silicon Biosystems S.p.A. is committed to equal opportunity in the terms and conditions of employment for job applicants without regard to race, colour, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin.



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