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Lead Systems Engineer, Regulatory
Waukesha, WI
Job Description
Job Description Summary Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation. The Lead Systems Regulatory Engineer takes part in new product development and sustaining engineering of industry leading CT scanners in various regulatory aspects to ensure the products are safe, legal and comply with national, regional, and global regulations.Job Description Roles and Responsibilities Assist and work with QA and engineering for regulatory inputs flow down and conformance management following ISO13485 principles. Provide regulatory input on product development processes such as system requirements, risk management, design reviews, and change management of released products.Identify product impacted safety and regulatory standards and manage the systems requirements flow down for the same.Assess regulatory compliance for the country specific labeling and packaging and manage the requirements flow down and traceability for the same.Identify relevant standards and participate in product development to ensure compliance to national, regional, or global regulatory requirements for US, EU, China, and other international marketsCreate technical files for regulatory compliance for product release milestones (including but not limited to Essential Principles Checklist, GSPR checklist etc)Assist Regulatory Affairs team in preparing regulatory submission packages for various regulatory bodies/regulations (FDA/510k, MDD/MDR, NMPA, KFDA etc)Works with technical experts across the organization (and globe) to implement tactical and strategic initiatives, continuous improvements regulatory engineering and manage regulatory change notifications impacting EngineeringAssist with inspections, audits, and/or other agency interactions with FDA or other regulatory bodiesDrives quality culture in all aspects of engineering deliverables and activitiesCommunicates and collaborates effectively with technical teams to deliver.Required Qualifications Bachelor's degree with 7+ years of related experience in regulatory affairs engineering; or a Master's degree with 5+ years of related experience in regulatory affairs engineering. (Bachelor's degree in Engineering, Technology, Math or Science majors)3+ years of work experience in product development in medical devices industryWorking knowledge of medical device regulations and experience with regulatory package preparation and submissions to regulatory bodies worldwide.Experience in Design Controls with respect to requirements, risk management, verification and traceability, including tools pertaining to manage these processes.Working knowledge of ISO13485 Quality systems, ISO14971 risk management methods, IEC60601-1 Safety StandardsDemonstrated ability to prioritize, pursue tasks to completion and attention to details.Desired Characteristics Audit experience with external regulatory bodiesExperience with Cybersecurity standards, IEC62366-1 Usability, and IEC62304 SDLC7+ years of experience with medical devices regulatory engineeringExcellent verbal and written communication skillsSelf-starter, energizing, results oriented, and collaborativeDemonstrated problem solving ability and results orientationOur 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-NR1GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer . 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 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).Relocation Assistance Provided: Yes
Job Summary
Company
GE Healthcare
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
7+ years
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