What are the responsibilities and job description for the Quality and Regulatory Affairs Manager position at Lumicity?
The Quality and Regulatory Compliance Manager at Lumicity is responsible for leading quality systems ensuring regulatory compliance for their medical devices. This role drives quality improvements and risk management across the product lifecycle.
Responsibilities:
- Manage quality systems and ensure regulatory compliance.
- Maintain ISO 13485, FDA, and EU MDR compliance.
- Drive quality improvements and risk management across the product lifecycle.
- Develop and implement QMS policies and procedures.
- Collaborate with cross-functional teams to achieve quality and regulatory objectives.
Requirements:
- 5-7 years of experience in quality systems and regulatory compliance.
- Strong knowledge of ISO 13485, FDA regulations, and EU MDR.
- Proven track record of driving quality improvements and risk management.
Lumicity offers a collaborative work environment and opportunities for professional growth and development.
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