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Compliance Senior Officer

1 tydzień temu


Poznań, Polska Sigma Software Pełny etat
We are looking for an experienced Senior Compliance Manager with a focus on the healthcare domain to enhance our expertise and help expand our business in this area.
As a key player in expanding our healthcare compliance services, you will actively participate in developing proposals, conducting gap analysis, and communicating with potential partners and clients.
Your expertise in regulatory requirements like MDR/IVDR, FDA, and GMP will be essential for driving business success, ensuring healthcare products meet regulatory requirements, and achieving CE marking.

Market compliance expertise:
Identify solutions to help clients achieve faster market entry and regulatory compliance
Communicate with potential clients in case the technical clarification is needed
Review client documentation to assess compliance with required regulations or requirements
Ensure selected partners can meet the necessary compliance requirements
Project involvement:
Assist in the initial phases of new projects by creating work plans and compliance documentation

Experience in preparing technical documentation for certification and submission to authorities
Familiarity with the principles and practices of computer system validation related to GAMP 5