Compliance Manager

2 days ago


Helsinki, Uusimaa, Finland Topcon Healthcare Solutions Oy Full time

As a Compliance Manager at Topcon Healthcare Solutions, you will play a critical role in ensuring the company's products meet regulatory requirements. This includes having a solid understanding and proven working experience with ISO 13485, EU MDR, and 21 CFR §820.

You will work closely with cross-functional teams to implement compliance best practices, evaluate suppliers and subcontractors, and provide training on applicable QMS processes. Your expertise in internal auditing, CAPA processes, and labeling requirements will be essential in ensuring the company's products comply with regulations.

Key qualifications for this role include:

  • Proven working experience with ISO 13485, EU MDR, and 21 CFR §820
  • Internal auditing certification or proven experience in internal auditing


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