Regulatory Affairs and Quality Assurance Engineer - Remote

Overview

The Regulatory Affairs and Quality Assurance Engineer plays a crucial role in ensuring the quality and compliance of medical device products. This position involves working closely with project teams to minimize risks associated with product design and realization while adhering to domestic and international regulations.

In Short

• Act as the quality representative on project teams.
• Ensure compliance with quality system requirements and regulations.
• Participate in design reviews and documentation.
• Support internal/external audits related to quality systems.
• Review engineering change notices for compliance.
• Provide guidance on design verification and validation protocols.
• Analyze process and product data for quality improvements.
• Maintain awareness of the cost of quality.
• Support regulatory submissions for medical device software.
• Collaborate with geographically diverse teams.

Requirements

• Bachelor’s degree in Computer Science, Engineering, or related field.
• 4-6 years of experience in healthcare software lifecycle.
• Experience with medical device regulations and standards.
• Knowledge of software development and quality assurance practices.
• Excellent communication and problem-solving skills.
• Ability to manage multiple projects simultaneously.
• Professional certification in quality assurance is a plus.
• Willingness to relocate for team collaboration.
• Strong analytical thinking abilities.
• Team player with interpersonal skills.

Benefits

• Opportunities for professional and personal growth.
• Supportive and inclusive work environment.
• Global community with diverse backgrounds.
• Engagement in pioneering healthcare breakthroughs.
• Access to resources for continuous learning.
• Flexible work arrangements.
• Competitive compensation and benefits package.
• Participation in impactful healthcare projects.
• Collaboration with experts in the field.
• Commitment to diversity and inclusion.