Senior Regulatory Affairs Analyst - AI Medical Devices
Abbott Laboratories
Abbott Laboratories in Alameda, CA is seeking a Senior Regulatory Affairs Specialist to support regulatory activities for digital health products and AI-enabled features. The role collaborates with software development and engineering to ensure documentation supports submissions and regulatory compliance for Class II software medical devices. The position focuses on cross-functional teamwork, regulatory strategy, and efficient processes, with a strong emphasis on digital health and SaMD across #J-18808-Ljbffr Abbott Laboratories
$90k - $180k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...female executives, and scientistsThis Senior Regulatory Affairs Specialist will work on-site out of our... ...and features including generative AI technologies designed to help millions...SeniorMedical deviceShift work- ...Years Experience: Must have 7 years of experiences in Medical Device Regulatory Affairs Considered as highly experienced with regulatory change assessments. Working knowledge in US Medical Device Submissions Participates in some of the following: continuous improvement...SeniorMedical device
- ...We are seeking an experienced Senior Regulatory Specialist with strong expertise in Medical Device Regulatory Affairs to support regulatory activities across the product lifecycle. The ideal candidate will have at least 7 years of experience in medical device regulatory...SeniorMedical device
$54 per hour
...Job Description Job Title: Regulatory Specialist Sr Job Description... ...ensuring timely approval of new medical devices and maintaining continued... ...in Medical Device Regulatory Affairs. Extensive experience and... ...of Artificial Intelligence (AI): We may use Artificial Intelligence...SeniorMedical deviceContract workTemporary workWork at office$172k - $344k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines... ..., CA currently has an opportunity for a Senior Counsel, Intellectual Property. Abbott... ...or similar space. Experience patenting AI, Machine Learning, Software, and Digital...SeniorMedical deviceContract workWork at officeWorldwide- Abbott in Alameda, CA, seeks a Senior Specialist in the Medical Events Group to manage timely review, documentation and filing of Medical Device Reports to the FDA, Medical Problem Reports to Health Canada, and related regulatory submissions for the division's products...SeniorMedical device
- ...partners, ensuring GMP/GCP compliance and timely delivery. Key responsibilities include developing execution plans, monitoring budgets and timelines, and collaborating with regulatory, QA, and medical affairs to align clinical and commercial goals. #J-18808-Ljbffr JobtailorSeniorMedical device
$100k - $200k
...- AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date:... ...businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus.Experience...Medical deviceWorldwide- About Eko Health Eko builds AI and digital tools to enable every... ...market globally by leading regulatory strategy across the full... ...Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly... ...of progressive regulatory affairs experience with Class II...Medical deviceWork at office
- A leading digital health company in Emeryville, CA is seeking a Product Quality Assurance Engineer to ensure compliance with industry regulations and internal standards. This hybrid role involves collaborating with product development teams to drive quality initiatives ...SeniorMedical device
$100k - $200k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...Opportunity This Principal International Regulatory Operations Specialist will work on-site... ...plus (such as RAC from the Regulatory Affairs Professionals Society.) 2-3 years of experience...Medical deviceWorldwideShift work- ...proactively identifying compliance risks, regulatory trends, and opportunities that impact... ...needs. Partner with Commercial, Medical Affairs, Clinical Development, Regulatory Affairs... ...pharmaceutical, biotechnology, medical device, or healthcare compliance, including experience...SeniorMedical deviceWork at office
- ...Regulatory Specialist with experience supporting sustaining activities, digital health/mobile... ...assessments, and U.S. regulatory affairs . The candidate should be able to independently... ...based systems experience Software as a Medical Device ( SaMD ) experience Experience with...Medical device
- ...Regulatory Affairs Associate We are seeking a Regulatory Affairs Associate to join one of our leading healthcare clients. Position... ...Minimum 2 years of experience in a regulated industry (Medical Device, Pharmaceutical, Nutrition, or Food). Regulatory Affairs...Medical device
$179.35k - $200.45k
About Eko Health Eko builds AI and digital tools to enable... ...it to patients at scale. As Senior Product Manager, Enterprise,... ...across Data Science/AI, Clinical Affairs, Regulatory, Sales, Marketing, and... ...venture-backed digital health or medical-device company. Experience with...SeniorMedical deviceWork experience placementWork at officeRemote work$132k - $200k
...Technology - IT /External /On-siteAs a Senior Business Systems Analyst, CRM at Penumbra, you will play a... ...application of Agentforce, Data Cloud, AI-enabled workflows, and other... ...related operational workflows preferred.• Medical devices, pharmaceutical, biotech, or other...SeniorMedical deviceTemporary workWork at officeLocal area$148.7k - $297.3k
...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000... ..., and scientists.The Opportunity This Associate Director Regulatory Affairs will work on-site out of our Alameda, CA location in the...Medical deviceWorldwideShift work- ...updated resume at ****@*****.*** Job Title: Senior Product Quality & Compliance Engineer Location: Alameda,... ...Description: Lead complaint tracking and trending for medical device products. Analyze complaint data to identify trends,...SeniorMedical device
$148.7k - $297.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...-grade platforms.We are seeking a Senior Manager, Platform Engineering. You are a... ...AIOps practices, and tooling, including AI driven anomaly detection, predictive alerting...SeniorMedical deviceWorldwide$130.7k - $261.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...with our new sensing technology. As Senior Brand Manager, MyFreeStyle US - App & Customer... ...platforms, marketing automation, and AI toolsExperience in product development...SeniorMedical deviceWorldwideShift work$148.7k - $297.3k
...helping people with Diabetes lead healthier, happier lives. As a Senior Manager, Forecasting and Strategy, you will be responsible... ...written and verbal communication skills. Experience in medical devices and/or biopharma industry. Deep understanding of healthcare related...SeniorMedical deviceTemporary work$130k
Penumbrainc is seeking a Senior R&D Engineer in Alameda, California, to lead the design and development of innovative medical devices. You will apply your expertise from concept through commercialization, ensuring technical leadership and guidance in developing new designs...SeniorMedical device$130k - $193k
Penumbra, Inc. in Alameda, CA is seeking a Senior R&D Engineer to design innovative medical devices addressing critical disease states. You will lead projects, create and manage documentation, and work collaboratively across teams. The ideal candidate has a Bachelor's...SeniorMedical device- ...Abbott is seeking a Senior Counsel for its Diabetes Care business in Alameda, CA. This role involves managing IP issues and delivering... ...background in patent law and extensive experience in the medical devices sector. The successful candidate will play a critical role in...SeniorMedical device
- ...the United States is seeking an experienced Senior Regulatory Specialist to support regulatory activities across the medical device product lifecycle. The candidate should... ...of experience in medical device regulatory affairs, with demonstrated expertise in regulatory...SeniorMedical device
- ...feature extraction. Architect and deploy on-device machine learning models targeting resource... ...you had… Experience in an FDA‑regulated medical device environment (design controls, IEC 6... ...processing, biomedical ML, or embedded AI are a plus. Familiarity with coding assistant...SeniorMedical deviceWork at office
- ...Programming to lead a team of statisti cal programmers supporting medical device clinical research. You will drive programming standards,... ...study outputs, and collaborate with Statistics, Data Management, Regulatory, and Clinical Study Management teams. You will develop...SeniorMedical device
$150k - $200k
...company in Alameda is seeking an FPGA/Firmware Engineer to architect and develop FPGA-based digital systems for next-generation medical devices. This role demands strong experience in firmware and RTL design, with responsibilities including optimizing designs and...SeniorMedical deviceFlexible hours- ...Procurement on supplier programs to enhance long-term supply continuity. The role emphasizes cross-functional influence, strategic supplier development, and improving quality and scalability across complex supply chains in a regulated medical device #J-18808-Ljbffr PenumbraincSeniorMedical device
$265k - $285k
...business operations, proactively manage regulatory and ethical risk, and build the... ...business needs. Partner with Commercial, Medical Affairs, Clinical Development, Regulatory Affairs... ...pharmaceutical, biotechnology, medical device, or healthcare compliance, including experience...SeniorMedical deviceWork at officeRemote work
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