- Terumo Medical Corporation (Elkton, MD)
- …cross-training with Complaints Specialist and others on adverse event reporting for MDR , Vigilance and MDPR. 9. Attend training to enhance product and PMS&V ... is responsible to assist the Post Market Surveillance and Vigilance group (PMS&V) with Medical Device Reporting ( MDR... Vigilance group (PMS&V) with Medical Device Reporting ( MDR ) to US and global health authorities (GHA) such… more
- 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
- Stryker (Fort Lauderdale, FL)
- Stryker is currently seeking a **Regulatory Reporting Specialist ** to join our Joint Replacement Division to be based hybrid in Weston, FL. **What you will do** As ... the **Regulatory Reporting Specialist ** , you will be responsible for ensuring the...Review reports of customer complaints and assess them for MDR / MIR reportability to FDA / Competent Authorities… 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
- 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
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