What are the responsibilities and job description for the Medical Device Compliance Specialist position at Lumicity?
Lumicity is a leading provider of innovative healthcare solutions, seeking a Medical Device Compliance Specialist to lead quality systems and ensure regulatory compliance for their vast array of medical devices.
This role focuses on maintaining ISO 13485, FDA, and EU MDR compliance while driving quality improvements and risk management across the product lifecycle. The ideal candidate will have proven experience managing Quality Management Systems (QMS) and regulatory compliance.
- Proven experience managing Quality Management Systems (QMS) and regulatory compliance.
- Strong knowledge of ISO 13485, FDA regulations, and EU MDR.
- Expertise in audits, risk management, supplier quality, and compliance training.
The successful Regulatory Affairs Manager - Quality Systems will be responsible for ensuring that all products comply with relevant regulations and standards, including ISO 13485 and FDA regulations.
This individual will work closely with cross-functional teams to drive quality improvements and implement effective risk management strategies.
- Excellent project management and cross-functional collaboration skills.
- Experience with pre-market approvals (e.g., 510(k)) and global regulatory intelligence.
