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Regulatory Compliance Expert

vor 1 Woche

PlanlesOuates, Genf, Schweiz Corsano Health Geneva Vollzeit
Key Responsibilities
The successful candidate will have primary responsibilities in:

• Maintaining and improving the QMS in compliance with ISO 13485 standards and CE MDR requirements.
• Ensuring all QMS-related documentation is up-to-date and properly controlled.
• Leading internal audits and supporting external audits.

Qualifications and Skills
To succeed in this role, you will need to possess the following qualifications and skills:

• Bachelor's degree in Engineering, in the field of life sciences / technical or medical devices; preferably knowledge of electronic devices (hardware, software, and firmware).
• 3+ years of experience in quality assurance within the medical device industry.
• Strong knowledge of ISO 13485 and CE MDR.
• Experience with software as a medical device (IEC 62304) is a strong advantage.
• Familiarity with FDA 21 CFR Part 820 is a plus.
• Hands-on experience in a startup or scale-up environment is highly desirable.
• Proficiency with document control systems and QMS software.
• Strong attention to detail and organizational skills.
• Excellent communication and collaboration skills.
• Fluency in English (written & spoken).