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Head of Regulatory Affairs and Quality Assurance

Company

Guided Solutions

Location

italy, italy

Type

Full-time

Our client is a clinical-stage R&D company that is developing an innovative treatment for solid tumour oncology. We are looking for an experienced medical device Regulatory Affairs and Quality Assurance (QA) professional to join the team in this executive role. The role manages the QA Director and reports to the CEO of the company.

PLEASE NOTE the role is remote but the company is based in Milan, Italy and travel will be required.

Key responsibilities:

  • Responsible for the regulatory strategies and submissions necessary to obtain regulatory clearance and/or approval.
  • Coordinate the implementation and maintenance of the company’s quality management system (QMS).
  • Support project teams during the development of new products and the product lifecycle providing guidance on the applicable regulatory requirements.
  • Prepare or review technical documentation.
  • Represent the company in regulatory, quality,...

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