Compliance and Quality Manager – SaMD
Employment Information
Job Description
Compliance and Quality Manager ensuring software compliance with FDA regulations for healthcare technology. Oversee quality standards and risk management for AI-integrated products.
Responsibilities:
- Ensuring certain software products comply with FDA regulations, ONC HTI-1, and other relevant standards.
- Staying updated on changes in regulations and implementing necessary adjustments to maintain compliance.
- Developing, implementing, and maintaining the QMS in accordance with FDA requirements and ISO 13485 standards.
- Conducting risk assessments and implementing risk mitigation strategies to ensure the safety and effectiveness of software products.
- Planning and conducting internal audits to ensure compliance with QMS and regulatory requirements.
- Developing and delivering training programs for employees on quality management and regulatory requirements.
- Investigating and managing quality incidents, including non-conformance and customer complaints.
Requirements:
- Bachelor’s degree in Engineering, Quality Management, or a related field
- 5 years of experience in medical device quality management, compliance, or related fields
- Master’s degree or professional certification (e.g., Certified Compliance & Ethics Professional, Certified Risk Manager, Certified Quality Engineer, Certified Quality Manager)
- Experience in supporting software development in the context of the FDA medical device regulations or development of software features incorporating artificial intelligence
Benefits:
- Excellent medical, dental, and vision benefits
- Mental health benefits through TelaDoc
- Prescription drug coverage
- Generous paid time off, plus 13 paid holidays
- Paid parental leave
- 100% vested 401(K) retirement plans
- Educational assistance up to $2500 per year
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