28 days old

Product Surveillance Specialist

GE Energy
Salt Lake City, UT 84111
**Job Description Summary**

This role manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.



GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.



**Job Description**



**Roles and Responsibilities**



+ Uses skills in post market product surveillance to handle complaints and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE Healthcare (GEHC) products.

+ Key contributor as part of a complaint handling unit

+ Identifying complaints that represent further regulatory evaluation

+ Resolves issues using established procedures. Consults People Leader or more senior team members for issues outside of defined parameters.

+ Collaborates with others to solve issues. Develops strong customer relationships and serves as the interface between customer and GE. Exchanges technical information, asks questions and checks for understanding.

+ Handles simple data entry work requiring face value check and correction.

+ Continuously working to improve the process



**Required Qualifications**



+ Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in a Quality or Regulatory Assurance related field).



**Desired Characteristics**



+ Excellent interpersonal, organizational, and influencing skills

+ Familiarly with 21CFR Part 820 and 803 (MDR)

+ Ability to respectfully communicate and collaborate with team members and customers

+ Ability to work independently & in a team setting

+ Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly

+ At least 1 year experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role

+ Familiarity with the application of medical device as it relates to patient safety



Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support.



\#LI-JC1



_This role is restricted to U.S. persons (i.e., U.S. citizens, permanent residents, and other protected individuals under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3)) due to access to export-controlled technology. GE will require proof of status prior to employment._



**Additional Information**



GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en\_global/desktop/assets/images/poster\_screen\_reader\_optimized\_w\_supplement.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.



GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).



**Relocation Assistance Provided:** No

Categories

Posted: 2021-03-15 Expires: 2021-04-14

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Product Surveillance Specialist

GE Energy
Salt Lake City, UT 84111

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