Sr. Associate Specialist, Product Surveillance, Clinical WHXR

GE HealthCare•Waukesha, WI

10d

About The Position

Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare. Uses in depth clinical knowledge to improve the complaint handling processes and enhance team understanding of products. Roles and Responsibilities: Apply clinical product knowledge and product surveillance expertise to review customer complaints, assess potential risk, and determine whether a complaint represents a potentially hazardous situation. Use an understanding of clinical workflows and how products are used in real-world settings to support accurate complaint evaluations and enhance team knowledge. Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR). Clearly communicate complex clinical or technical information in a way that is easy for others to understand. Build strong working relationships with colleagues across the Complaint Handling Unit and provide guidance and support to new team members. Collaborate with cross-functional teams including Medical Safety, Engineering, Regulatory Affairs, and hospitals to gather information and support complaint investigations / determine reportability in alignment with regulatory requirements. Work independently on day-to-day responsibilities while following established procedures and knowing when to seek guidance on more complex situations. Use clinical expertise, analytical thinking, and sound professional judgment to investigate issues, solve problems, and make well-supported decisions that impact patient safety. Draw on resources and subject matter experts across the organization as needed. Timely complaint handling, reporting, and training. Contribute to improving team processes, projects, and standard ways of working within Product Surveillance.

Requirements

Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 8 years of experience in Medical Device Manufacturing Industry or working in a clinical setting)
Minimum 2 years of experience in a clinical setting interfacing with X-Ray, Bone Mineral Density, or Mammography medical devices.

Nice To Haves

Product specific knowledge and/or experience using X-Ray, Mammography, or Bone Mineral Density GEHC manufactured medical devices
Prior experience working with Microsoft Office products (particularly Excel)
Demonstrated knowledge of 21CFR Part 820
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems, even amongst competing priorities
Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
Excellent interpersonal, organizational, and influencing skills
Ability to analyze and process data, and draw the appropriate conclusions
Experience with Lean principles or demonstrated experience implementing process improvements

Responsibilities

Apply clinical product knowledge and product surveillance expertise to review customer complaints, assess potential risk, and determine whether a complaint represents a potentially hazardous situation.
Use an understanding of clinical workflows and how products are used in real-world settings to support accurate complaint evaluations and enhance team knowledge.
Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR).
Clearly communicate complex clinical or technical information in a way that is easy for others to understand.
Build strong working relationships with colleagues across the Complaint Handling Unit and provide guidance and support to new team members.
Collaborate with cross-functional teams including Medical Safety, Engineering, Regulatory Affairs, and hospitals to gather information and support complaint investigations / determine reportability in alignment with regulatory requirements.
Work independently on day-to-day responsibilities while following established procedures and knowing when to seek guidance on more complex situations.
Use clinical expertise, analytical thinking, and sound professional judgment to investigate issues, solve problems, and make well-supported decisions that impact patient safety. Draw on resources and subject matter experts across the organization as needed.
Timely complaint handling, reporting, and training.
Contribute to improving team processes, projects, and standard ways of working within Product Surveillance.