What are the responsibilities and job description for the Regulatory Affairs Manager - Quality Systems position at Lumicity?
Lumicity seeks a highly skilled Quality and Regulatory Lead to join their team and take ownership of quality systems and regulatory compliance.
The successful candidate will have a strong understanding of ISO 13485, FDA regulations, and EU MDR, as well as extensive experience in audits, risk management, and compliance training.
- 5-7 years of experience in quality systems and regulatory compliance.
- Preferred: Experience with Class II medical devices and GMP.
The Quality and Regulatory Lead will be responsible for maintaining ISO 13485, FDA, and EU MDR compliance while driving quality improvements and risk management across the product lifecycle.
This individual will also provide expert guidance on quality systems and regulatory compliance, ensuring that all products meet the required standards.
