Manager, Regulatory Affairs - MR at GE Healthcare

Waukesha, Wisconsin, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Technology, Medical ImagingIndustries

Requirements

Bachelor's Degree in a Scientific, Engineering, or Regulatory Affairs 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
Experience of regulatory people management/project management/program management and regulatory agency interactions
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

Responsibilities

Provides regulatory strategy and direction to the Premium Segment of the Magnetic Resonance Imaging business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally
Manages a team of Regulatory Affairs professionals as well as an individual contributor
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

Skills

Key technologies and capabilities for this role

Regulatory AffairsRegulatory StrategyPremarket SubmissionsPostmarket ComplianceHealthcare RegulationsGlobal Regulatory BodiesTeam ManagementProject Leadership

Questions & Answers

Common questions about this position

What qualifications are required for the Manager, Regulatory Affairs position?

Candidates need a Bachelor's Degree in a Scientific, Engineering, or Regulatory Affairs discipline or a minimum of 8 years work experience, plus a minimum of 4 years in Regulatory Affairs / Quality Assurance, 4 years in the medical device or pharmaceutical industry, and experience in regulatory people management/project management/program management and regulatory agency interactions.

Is this a management role, and what does it involve in terms of team leadership?

Yes, the role manages a team of Regulatory Affairs professionals while also serving as an individual contributor.

What is the employment type for this position?

This is a full-time position.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What experience makes a strong candidate for this regulatory affairs manager role?

Strong candidates will have at least 4 years in Regulatory Affairs/Quality Assurance and medical device/pharmaceutical industry, plus proven experience in regulatory people management, project/program management, and interactions with regulatory agencies.

GE Healthcare

Healthcare technology and data analytics provider

About GE Healthcare

GE Healthcare provides a range of healthcare technologies and services aimed at improving patient care. Its main products include imaging systems, mobile diagnostic devices, patient monitoring solutions, and advanced software for data analysis. These products help medical professionals make informed decisions and enhance the efficiency of healthcare delivery. Unlike many competitors, GE Healthcare invests significantly in research and development, allocating $1 billion each year to innovate and enhance its offerings. The company’s goal is to support healthcare providers in delivering better patient outcomes, as evidenced by its technology supporting over 300,000 patients daily and managing 2 billion patient scans each year.

Chicago, IllinoisHeadquarters

1892Year Founded

N/ACompany Stage

Data & Analytics, HealthcareIndustries

10,001+Employees

Risks

Emerging AR technologies increase competition in medical imaging.

Regulatory challenges may delay AI application expansions in healthcare.

Dependence on clinical trial success for new product market positioning.

Differentiation

GE Healthcare invests $1 billion annually in R&D for product innovation.

The company supports over 300,000 patients daily with its healthcare technologies.

GE Healthcare's AIR Recon DL offers 3D motion-insensitive imaging for enhanced MRI quality.

Upsides

Acquisition of Caption Health expands AI-powered ultrasound capabilities.

Successful Phase III trial of [18F]flurpiridaz enhances coronary artery disease detection.

Collaboration with Wayra accelerates digital health innovation in EMEA.

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