Quality and Regulatory Affairs Associate

📋 Description

• Maintain ISO 13485 QMS and support MDSAP readiness
• Post-production QA: surveillance, CAPA, doc control in eQMS
• Coordinate with Notified Bodies and external reviewers
• Document control and eQMS administration
• Training and records management in the eQMS

🎯 Requirements

• Bachelor’s degree in Life Sciences, Engineering, or Regulatory Affairs
• 2–3 years QA/Regulatory experience in medical devices
• ISO 13485 knowledge; exposure to EU MDR, UK MHRA/UKCA
• Experience compiling submission-ready technical documentation
• Strong technical writing, organization, detail orientation, multitasking

🎁 Benefits

• Competitive salary
• Healthcare, dental, mental health
• Retirement savings options
• Generous paid time off