Compliance SME – Medical Device Software

Job not on LinkedIn

September 16

Apply Now

Receive Emails with Similar Jobs

Codvo.ai

WebsiteLinkedInAll Job Openings

AI • Cybersecurity • SaaS

Codvo. ai is a technology company that specializes in delivering strategic enterprise solutions through advanced AI-driven innovation. They focus on transforming enterprise data into measurable value by helping businesses accelerate growth with custom AI implementations tailored to meet the specific challenges of various industries. Their extensive service offerings include AI/ML automation, application development, data analytics, cybersecurity, and digital transformation, ensuring that organizations can thrive in a rapidly evolving digital landscape.

51 - 200 employees

Founded 2019

🔒 Cybersecurity

☁️ SaaS

📋 Description

• Lead and support regulatory compliance initiatives for medical device software (SaMD). • Lead classification and regulatory pathway analysis for SaMD under FDA guidelines, including 510(k) submissions. • Facilitate early engagement with FDA through pre-submission meetings. • Implement and maintain QMS in accordance with ISO 13485:2016. • Oversee document control, change management, and supplier qualification processes. • Ensure integration of risk management into QMS activities. • Ensure software development processes align with IEC 62304 standards. • Manage software safety classification (Class B or higher). • Oversee development planning, requirements analysis, design, implementation, verification, validation, and release. • Apply ISO 14971 principles to identify, evaluate, and mitigate risks throughout the product lifecycle. • Collaborate with cross-functional teams to ensure risk controls are effectively implemented and documented.

🎯 Requirements

• Bachelor's or Master’s degree in Engineering, Life Sciences, or related field. • 7+ years of experience in regulatory compliance for medical devices or SaMD. • Proven expertise in FDA regulations, ISO 13485, IEC 62304, and ISO 14971. • Strong understanding of software development and validation processes. • Excellent communication and documentation skills. • Preferred: Experience with international regulatory bodies (e.g., EU MDR, Health Canada). • Preferred: Certification in Regulatory Affairs or Quality Management. • Preferred: Familiarity with digital health technologies and AI/ML in medical devices.

🏖️ Benefits

• Opportunity to work on cutting-edge medical technologies. • Collaborative and inclusive work environment. • Competitive compensation and benefits.