Job Description Summary
The GHEC Ultrasound segment, a fast-growing business in GE HealthCare, is the global leader in ultrasound medical devices and solutions. The portfolio spans the continuum of care to enable customers with ultrasound screening, diagnosis, treatment and monitoring of diseases. Our customers are seeking to improve efficiency in radiology and beyond and increase user confidence to provide better clinical outcomes continues to grow. Consequently, the need for AI, digital solutions, and automation, connecting devices and software in one seamless ecosystem continues to proliferate.The Caption Health SBU focuses on clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans.
The Sr. Regulatory Affairs Specialist provides regulatory strategy and direction to the Ultrasound business regarding healthcare industry regulatory requirements for product launch, premarket submissions/ registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Possess a deep knowledge base on worldwide healthcare regulations and guidelines that enables successful submission processes throughout product development cycles. Collaborate and communicate effectively with internal partners in a dynamic work environment.
Job Description
Essential Responsibilities:
In this role you will:
- Prepare or coordinate the preparation of pre-submissions, de novo requests, 510(k) submissions, and technical files for CE marking.
- Author technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents and execute through market entry.
- Participate on project teams, providing regulatory strategy, timelines, and deliverables.
- Work collaboratively with company engineers, providing informed, creative, and effective solutions to the challenges the design team faces in getting products through to commercial release.
- Review change orders and assess regulatory impact of product changes on US, EU and/or international regulatory strategy and submissions per standard procedure.
- Review labeling, design control documentation, and promotional materials and assess compliance against relevant regulations and product requirements.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Identify and interpret statutes, regulations, policies, and guidance, communicating how these impact product development, manufacturing, and/or marketing.
- Develop and maintain regulatory affairs department procedures and process improvements.
- Perform other duties as assigned.
Basic Qualifications:
- Bachelor's degree in Engineering, Computer Science, the natural or biological sciences, or equivalent.
- 5-7 years of experience in Regulatory Affairs or equivalent experience.
- Excellent technical writing and communications skills with a highly analytical, detail-oriented approach to solving complex problems.
- Strong planning and organizational skills, managing multiple deliverables at once.
- Strong teamwork ethic, passion for learning, and desire to seek new challenges.
- Ability to identify project or compliance risks and escalate when necessary.
- Proficient with Microsoft 365 or similar software.
Eligibility Requirements:
- This position is based in the United States only. Legal authorization to work in the U.S. is required. GE HealthCare may agree to sponsor an individual for an employment visa now or in the future if there is a shortage of individuals with particular skills.
- Must be willing to travel as required.
Desired Characteristics:
- Experience with Software as a Medical Device (SaMD), artificial intelligence, medical imaging, and maternal/fetal/obstetric devices a plus.
- Experience in international regions such as Africa and Asia is a plus.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare 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 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
Application Deadline: October 21, 2024
United States
