Job Description Summary

Uses regulatory knowledge combined with skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective and preventive actions for the safe and effective use of GE HealthCare Ultrasound products.

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:

• Effectively manages a team of direct or indirect report(s), including mentoring, coaching and development planning. Monitors team performance based on goals and metrics.

• Oversees daily complaint handling activities, including identification and escalation of potentially reportable events.

• Completes leader evaluations for direct reports on time, when applicable

• Provides continues feedback to team of direct/indirect reports.

• Create, maintain, and plan training material for team and new hires related to post market regulation requirements.

• Provides support to team during peak holiday time, including completing complaint handling activities as needed.

• Analyze data on patient safety and risk, ensuring compliance with applicable post market regulations.

• Conveys performance expectations and may handle sensitive issues.

• Ensure zero repeat findings from previous internal and external audits within area of responsibility.

• Responds to regulatory inquires and provides data for Post Market Surveillance reports, including analysis of public reporting databases (MAUDE, etc.).

• Own post market regulatory activities, including Ultrasound Reportable Malfunction List, Post Market Surveillance Plans, and regulatory team training for the Ultrasound business.

• Support business during internal and external audits of GE Healthcare’s Quality Management System (QMS).

• Communicate post market metrics to business and site leaders.

• Has knowledge of complaint handling best practices and how Product Surveillance team integrates with other areas of the business.

• Is aware of the product competition and the factors that differentiate the product in the market

• Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems.

• Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking.

• Uses multiple internal and limited external sources outside of own team to arrive at decisions.

• A job at this level requires a people leader with the ability to hire and develop talent.

• Jobs at this level function with some autonomy but are subject to functional practices and precedents that are covered by well-defined policies.

• The job allows modification of procedures and work practices as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).

• Accountable for quality of own work and meeting or exceeding team’s quality metrics.

• Continuously works on identifying opportunities to improve the complaint handling and adverse event reporting process.

• Educates, trains, & advises company professionals regarding post market complaint handling process.

• Aware of and comply with the GE HealthCare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position.

• Complete all planned Quality & Compliance training within the defined deadlines.

• Identify and report any quality or compliance concerns and take immediate corrective action as required

• Frequently leads projects within the team or across business functions.

• Work closely with other professionals across the company to ensure compliance to global regulations and reporting requirements related to post market surveillance.

• Collect, summarize & evaluate performance metrics of timeliness of global reporting decisions to identify program weaknesses & drive improvements in procedures or oversight.

• Educate, train, & advise company professionals to ensure compliance with regulatory reporting requirements and post market complaint handling process.

• Ability to communicate clearly in English, verbally and in writing.

Required Qualifications:

• Bachelor’s degree from an accredited university or college; OR high school diploma/GED and a minimum of 6 years’ work experience in medical device or pharmaceutical industry.

• A minimum 6 years’ work experience in medical device or pharmaceutical industry in complaint handling, regulatory affairs, or adverse event reporting.

Desired Characteristics:

• Experience in medica device industry preferred.

• Strong working knowledge of Medical Device regulations, such as FDA CFR 21 Parts 820, 803, 806 & 1002/03; ISO 13485; MDD/MDR; CMDR.

• Regulatory Affairs Certification (RAC).

• GE HealthCare Product-specific knowledge – Ultrasound.

• Ability to demonstrate GE HealthCare Operating Principles.

• Ability to work independently & in a team setting.

• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

• Excellent verbal, written, and presentation skills.

• Excellent interpersonal, organizational, and influencing skills.

• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems.

• Ability to analyze and process data, and draw the appropriate conclusions.

• Excellent leadership skills through demonstrated leadership responsibilities.

• Experience managing direct or indirect reports.

• Experience creating successful training curriculum.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

#LI-DRJ

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Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.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 HealthCare 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).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No