Medical Device QA/RA Specialist

Medical Device QA/RA Specialist
Location:

Rehovot (Hybrid), IL, IL

Job ID: 55084
Category: Manufacturing & Operations

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.

What you’ll be doing

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