Full-Time
Associated Director Regulatory Affairs CMC
Regulatory Affairs, CMC
Posted on 8/19/2025
GE Healthcare
1-10 employees
Imaging, monitoring, and healthcare IT solutions
Compensation Overview
$128.8k - $193.2k/yr
Remote in USA
Remote
U.S. based positions only.
 Legal & Compliance (1) |
|---|
- Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (Doctor of Pharmacy (PharmD) or MSc in Radiopharmacy preferred)
- Minimum 3 years of experience in Regulatory Affairs (CMC focus), with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals
- Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds
- To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products
- Build, or provide input to, submission strategy documents by defining variation type, data required to support submission, and submission documents required for the submission package. Review and approve published output.
- Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
- Prepare and maintain CMC sections of global regulatory submissions, including INDs, IMPDs, NDAs, MAAs, variations, and supplements
- Provide consistent expert advice to the organisation, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues
- To direct, manage and review outsourced regulatory CMC related regulatory activities for the assigned projects/products.
- Maintain registration tracking information and assist in the development of good document management practice standards.
- Interact with regulatory agencies during scientific advice, pre-approval inspections, and post-approval queries
- To support QA during audits and inspections as required.
- Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters)
- Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry
- Experience of regulatory project management and regulatory agency interactions
- Experience with Veeva RIM or other registration tracking tools.
- Ability to work across cultures/countries/sites.
GE Healthcare Systems provides medical technologies and digital infrastructure to improve diagnosis, treatment, and monitoring of patients. Its products include imaging systems, mobile diagnostic devices, patient monitoring tools, and healthcare IT software that work together as hardware, software, and services to support hospitals, clinics, and researchers. The company differentiates itself with a large, integrated ecosystem, strong focus on AI analytics, and a global service network backed by substantial R&D investment. Its goal is to improve patient outcomes and the efficiency of healthcare delivery by enabling accurate diagnoses, effective treatments, and scaled operations.
Company Size
1-10
Company Stage
IPO
Headquarters
Chicago, Illinois
Founded
1892
Simplify's Take
What believers are saying
- FDA-cleared MIM Contour ProtégéAI+ 2.0 accelerates radiation oncology planning.[1]
- DeepHealth breast screening integration improved detection 21% in U.S. studies.
- Intelerad strengthens cloud enterprise imaging and adjacent digital infrastructure.
- Sonic DL and helium-free MRI can boost workflow speed and operating economics.
- Record backlog and 2025 revenue of $20.6 billion support future software and services growth.
What critics are saying
- Memory-chip, oil, and freight inflation already forced 2026 profit guidance lower.
- Intelerad integration can delay cloud imaging revenue and distract sales execution.
- FDA or clearance delays can slow AI product refreshes and MRI adoption.
What makes GE Healthcare unique
- GE HealthCare spans imaging, ultrasound, patient care, and pharmaceutical diagnostics.[1]
- Its 2023 spin-off created a focused, publicly traded healthcare technology company.[1]
- The company combines hardware, software, and services across 100-plus countries.[1][3]
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Company News
GE HealthCare has announced a digital integration between its bkActiv intraoperative ultrasound system and Medtronic's Stealth AXiS surgical navigation system, now commercially available for cranial procedures. The integration allows neurosurgeons to use bkActiv as a plug-and-play real-time visualisation solution during procedures. The system addresses "brain shift", a natural movement of the brain during surgery that reduces pre-surgical image accuracy. bkActiv provides live ultrasound images alongside pre-operative MRI or CT scans on the Stealth AXiS system, recently cleared by the FDA for cranial procedures in the United States. Features include sterilisable transducers, sensitive colour Doppler for blood flow visualisation, and remote control capability from the sterile field. The companies will showcase the integration at the American Association of Neurological Surgeons Annual Scientific Meeting in May 2026.
GE HealthCare is showcasing its cardiology portfolio at ACC.26, featuring AI-enabled imaging technologies and software solutions addressing cardiovascular disease, which kills over 900,000 Americans annually. The company received US FDA 510(k) clearance for Photonova Spectra, a photon-counting CT system with proprietary Deep Silicon detectors designed to provide ultra-high-definition cardiac imaging and improved plaque characterisation. GE HealthCare introduced ReadyFix fleet management solution for MAC VU360 ECG workstations, enabling remote diagnostics and software deployment to optimise device uptime. The company also announced a US collaboration with Gentuity, connecting customers with HF-OCT and Vis-Rx PRIME Micro-Imaging Catheter for enhanced coronary procedure visualisation. The $20.6 billion company serves patients globally with imaging, diagnostics and AI solutions across the cardiology care pathway.
GE HealthCare has received FDA 510(k) clearance for Photonova Spectra, a photon-counting computed tomography system powered by its Deep Silicon detector technology. The system directly counts individual photons and measures their energy, enabling higher spectral and spatial resolution compared to conventional CT systems that first convert X-rays into visible light. Photonova Spectra features 8-bin energy resolution, wide detector coverage and rapid 0.23-second rotation speed, supporting fast acquisition and detailed visualisation across multiple clinical specialties. The system automatically captures spectral and ultra-high definition spatial data simultaneously without requiring special protocols. The technology incorporates NVIDIA accelerated computing to process up to 50 times more data than conventional CT systems. GE HealthCare is collaborating with institutions including UW-Madison and Stanford Medicine to explore clinical applications and imaging protocols.
GE HealthCare has appointed Kevin Lobo, chair and CEO of Stryker Corporation, to its board of directors effective 13 March. Lobo brings over 25 years of medical technology, operational and financial leadership experience to the role. Lobo has served as Stryker's CEO since October 2012 and board chair since July 2014. Previously, he held leadership positions at Johnson & Johnson, including president of Ethicon Endo Strategy, and at chemical and pharmaceutical company Rhône-Poulenc. His early career included finance roles at KPMG, Unilever and Kraft Canada. GE HealthCare chairman H. Lawrence Culp said Lobo's clinical expertise and track record of driving innovation would strengthen the board as the company pursues growth priorities in personalised, connected healthcare.
Arthur J. Gallagher, an insurance brokerage and consulting firm, stands out amongst cash-producing stocks with a 12.8% trailing 12-month free cash flow margin. The company has demonstrated strong revenue growth of 17.9% annually over the past two years and earnings per share growth of 17.7% annually over five years, outperforming peers. In contrast, Grand Canyon Education faces challenges with underwhelming student numbers and modest earnings growth of just 7.2% annually over five years, despite a 21.6% free cash flow margin. GE HealthCare also struggles with weak 2.7% annual revenue growth over two years and limited organic expansion. Arthur J. Gallagher, operating in approximately 130 countries, provides insurance brokerage, reinsurance and consulting services globally.