- Medtronic (Los Angeles, CA)
- …7+ years of experience in Quality and/or Regulatory, including direct experience in MDR / vigilance systems implementation. OR Advanced degree with 5+ years of ... Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate implementation or… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** As a Medical Safety Specialist II (MSSII) you will have an integral role in the ... knowledge and experience working with: + Various regulations (HIPPA, EU- MDR , FDA 21 CFR Part 803, 806, 820) +...+ Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience (Medical Device preferred… more
- Philips (Murrysville, PA)
- **PMS Complaint Handling Specialist ** **In this role you** Are responsible for overseeing complaint handling processes, facilitating communication between ... and training new specialists, leading investigation teams, and ensuring accurate vigilance reporting to enhance product quality and customer satisfaction. **Your… more
- Meta (New York, NY)
- **Summary:** We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical ... other innovative devices. **Required Skills:** Medical Devices, Regulatory Affairs Specialist Responsibilities: 1. Interact directly with FDA and/or indirectly with… more