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GE HealthCare · 3 days ago

Manager, Regulatory Affairs - MR

Waukesha, WI

Full-time

Onsite

Mid, Senior Level

$132K/yr - $198K/yr

4+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. This position provides regulatory strategy and direction for the Magnetic Resonance business regarding healthcare industry regulatory requirements, focusing on product launch, premarket submissions, and post market compliance.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

Responsibilities

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally

Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development and ensures delivery within area of responsibility

Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field

Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team. These jobs have significant input into their priorities. Jobs at this level tend to be covered by professional practices and policies but these are shaped by the role. Working within broad guidelines and policies, roles at this level have moderate autonomy, requiring high levels of evaluative judgment

Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions

Qualification

Regulatory AffairsQuality AssuranceMedical Device IndustryRegulatory Affairs CertificationProject ManagementCommunication SkillsTeam LeadershipProblem Solving

Required

Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 8 years work experience

A minimum of 4 years Regulatory Affairs / Quality Assurance experience

A minimum of 4 years' experience in the medical device or pharmaceutical industry

Strong experience with management of regulatory projects in global regulatory organizations and working globally across different cultures

Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer's requirements

Preferred

Experience with Radiological imaging preferred

Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects

Ability to document, plan, market, and execute programs. Established project management skills

Advanced degree in scientific, technology or regulatory affairs disciplines

Regulatory Affairs Certification (RAPS)

Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies

Strong team leadership skills, facilitates teamwork, proven ability to lead and inspire

Ability to make sound business judgments both with independence and knowing when to seek advice and support

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