Job Description:
Qualifications:
• Bachelor's degree in Quality Management, Regulatory Affairs, Life Sciences, or a related field.
• Minimum of 5 years of experience in QMS, quality assurance, regulatory compliance, or related roles.
• Software/AI experience.
• Strong knowledge of FDA and EU regulatory requirements, specifically with QMS.
• Experience with CAPA processes, document management, and regulatory submissions.
• Familiarity with cybersecurity audit procedures and standards.
• Excellent communication skills, with a keen attention to detail and ability to manage multiple priorities.
Preferred Qualifications:
• Certification in Quality Management or Regulatory Affairs (e.g., ASQ, RAPS).
• Hands-on experience with QMS software systems.
• Experience in the medical device or healthcare tech industry.
