Medical Device Qa/Ra Specialist
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Job Description
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
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
