Senior Associate Specialist, Product Surveillance Clinical, Ultrasound
2 days ago
As a Senior Associate Specialist in Product Surveillance Clinical, you will play a critical role in ensuring the safe and effective use of GE HealthCare Ultrasound products. You will utilize your clinical product knowledge and skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective and preventive actions.
Key Responsibilities- Evaluate complaints from a patient safety perspective and identify those that require further evaluation according to global regulations.
- Assess risk by providing guidance on clinical workflow and product usage to identify potentially hazardous situations.
- Manage risk by identifying product safety issues, triaging complaints for further investigation, and performing complaint closure according to set criteria.
- Ensure timely submissions of safety and regulatory reports to regulators.
- Provide objective evidence of complaint handling processes through compliant documentation.
- Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations.
- Collaborate with Medical Directors and provide clinical expertise into Risk Management processes.
- Support business during internal and external audits of GE HealthCare's Quality Management System (QMS).
- Bachelor's degree or equivalent in medical science, health sciences, or a healthcare-related field.
- Minimum 4 years of Ultrasound Technologist clinical experience or equivalent.
- GE HealthCare Product-specific knowledge - Ultrasound.
- Quality, Regulatory, or Post Market experience preferred.
- Demonstrated knowledge of ISO 13485, 21CFR part 820, ISO 14971.
- Ability to demonstrate GE HealthCare Operating Principles.
- Ability to work independently and in a team setting.
- Demonstrated experience prioritizing conflicting demands in an extremely fast-paced environment.
- Excellent verbal, written, and presentation skills.
- Excellent interpersonal, organizational, time management, and influencing skills.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. We are an Equal Opportunity Employer and welcome applications from diverse candidates.
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Milwaukee, Wisconsin, United States GE Healthcare Full timeJob SummaryAs a Senior Associate Specialist in Product Surveillance Clinical, you will play a critical role in ensuring the safe and effective use of GE HealthCare Ultrasound products. You will utilize your clinical product knowledge and skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective...
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