Medical Device QA/RA Specialist

At Stratasys, we are leading the global shift to additive manufacturing, delivering innovative 3D printing solutions across industries such as healthcare, aerospace, automotive, and consumer products.

We are looking for a Regulatory Affairs Specialist to join our Medical Devices team and support the full regulatory lifecycle of our products—from change management to post-market activities.

Regulatory Change Management & Lifecycle

• Execute regulatory change management activities in line with approved strategies and internal procedures
• Assess change impact, coordinate cross-functional inputs, and ensure timely and compliant implementation
• Track global implementation of changes (labeling, IFUs, UDI, technical documentation)
• Support audits and inspections, ensuring readiness and proper documentation

Technical Documentation & Compliance

• Maintain and update technical files in compliance with EU MDR, FDA, and global requirements
• Update Annex II/III documentation, labeling, and administrative content
• Ensure documentation is accurate, version-controlled, and aligned with product configurations
• Support ongoing documentation reviews and risk management alignment

Complaint Handling & Post-Market

• Manage complaint handling activities, including intake, investigation coordination, and closure
• Perform complaint trending and support reporting activities
• Support vigilance reporting (EU MDR, FDA MDR) and post-market surveillance (PMS)

Regulatory Coordination & Reporting

• Track regulatory projects, submissions, renewals, and key timelines
• Support submission preparation and ensure completeness of documentation
• Monitor commitments and prepare status updates and summaries for leadership

Requirements:

• B.Sc. in Regulatory Affairs, Engineering, Life Sciences, or related field
• 5+ years of experience in Regulatory Affairs (Medical Devices)
• Strong knowledge of FDA, EU MDR, ISO 13485, and global regulatory requirements
• Experience with Class II / Class III devices
• Familiarity with UDI, labeling, and post-market activities
• Strong communication, organization, and cross-functional collaboration skills
• Hands-on, detail-oriented, and able to manage multiple priorities