Compliance and Quality Manager – SaMD

Job not on LinkedIn

2 days ago

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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WellSky

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Healthcare Insurance • SaaS • Artificial Intelligence

WellSky is a leading healthcare technology company dedicated to improving healthcare and community care outcomes worldwide. By offering comprehensive software solutions and analytics, WellSky enables healthcare providers, payers, and community organizations to collaborate and enhance care quality and accessibility. Their focus spans intelligent care management, connected care networks, and transformative analytics, aiming to create more efficient, inclusive, and sustainable healthcare systems. WellSky addresses social determinants of health and emphasizes patient and family engagement, supporting care in various settings including home, long-term, and acute care.

1001 - 5000 employees

Founded 1980

⚕️ Healthcare Insurance

☁️ SaaS

🤖 Artificial Intelligence

💰 Private Equity Round on 2020-07

📋 Description

• 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