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GE HealthCare · 18 hours ago

Director, Quality & Regulatory Business Development-2

Arlington Heights, IL

Full-time

Onsite

Director/Executive

$142K/yr - $214K/yr

7+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. The Director of Quality & Regulatory Business Development is responsible for managing and improving business development capabilities, ensuring compliance with internal and external requirements, and leading projects to enhance product quality and regulatory standards.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

Responsibilities

Executes against the Quality & Regulatory Business Development Process. This includes scheduling, preparation, execution, reporting, and follow-up activities associated with Business Development activities; identification and communication of high-risk issues; reporting compliance concerns and recommended improvements to business leadership; developing and ensuring strategy is executed to current industry practices and regulatory expectations

Standardization of processes, tools, and performance management system

Requires ability to lead functional teams or projects with indirect resources and medium to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view

Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation

Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GE HealthCare policy objectives

Regularly advises Quality and Regulatory management in business development. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required

Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision

Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results

Qualification

Medical device experiencePharmaceutical industry experienceQuality compliance resolutionPharma QMS requirementsASQ CertificationLean CertificationProject management skillsCommunication skillsIntegrityProblem-solving ability

Required

Master's Degree and a minimum of 7 years' experience in the medical device or pharmaceutical industry; or Bachelor's Degree and a minimum of 9 years' experience in the medical device or pharmaceutical industry; or will consider a High School Diploma and a minimum of 13 years' of progressive responsibility in the medical device or pharmaceutical industry

Minimum of 5 years' Experience driving Global programs to resolve quality compliance issues (directly)

Experience with Pharma QMS requirements and regulatory requirements including but not limited to FDA 21 CFR Part 211 & 212, Eudralex and PICS

Preferred

Demonstrated ability to lead programs /projects

Ability to document, plan, market, and execute programs

Established project management skills

Demonstrated ability to analyze and resolve problems

ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt)

Simplifying strategy into specific actions with clear accountability

Making decisions with speed and accuracy based on best available information

Communicating priorities clearly and concisely

Ability to interface with top organizational leadership and internal and external customers

Ability to energize others by building a connection with the team through personal involvement and trust

Providing feedback and coaching to develop others

Strong oral and written communication skills in English

Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

Ability to travel domestically and internationally up to 20%

Benefits

Medical

Dental

Vision

Paid time off

A 401(k) plan with employee and company contribution opportunities

Life

Disability

Accident insurance

Tuition reimbursement

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees