Senior Regulatory Affairs Director - Medical Devices
Thornton Tomasetti
Abbott in Alameda, CA is seeking an Associate Director Regulatory Affairs to shape global regulatory strategies across the product life cycle in Diabetes Care. We focus on innovative glucose monitoring technologies and drive strategic regulatory initiatives. You will lead and develop high-performing teams, interface with agencies, and drive regulatory submissions for US and EU, ensuring compliance and timely approvals. #J-18808-Ljbffr Thornton Tomasetti
- Epia Neuro in Alameda, CA seeks a senior electrical hardware engineer to own and evolve electrical architecture and hardware across... ...research prototypes move toward production‑intent Class III medical devices, coordinating technical decisions and documentation across...SeniorMedical device
- 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
- Penumbra, Inc. in Alameda, CA, is seeking a Senior Development Quality Engineer to lead... ...team, design and qualify new life-saving devices, implement design control, and ensure... ...focusing on accuracy, problem solving, and regulatory readiness. #J-18808-Ljbffr Penumbra,...SeniorMedical device
- Eko Health in Emeryville, CA, is seeking a senior electrical engineer to design and qualify electronics for our digital... .... You’ll lead root cause analysis, work with contract manufacturers, and contribute to regulatory and DFMEA processes for医疗 devices. #J-18808-Ljbffr EkoSeniorMedical deviceContract work
- Abbott Diabetes Care in Alameda, CA is seeking a Process Engineer III to support manufacturing equipment and processes. This role drives cost reductions, improves quality, and scales production in a regulated setting. You will design, verify, and validate processes, lead...SeniorMedical device
- ...is seeking a seasoned mechanical design engineer to lead new medical device development and design transfer. You will address complex technical... ...cross-functional programs with Operations, Quality, and Regulatory teams. The role emphasizes design for manufacturability,...SeniorMedical device
- Penumbra, Inc., headquartered in Alameda, California, seeks a Senior Industrial/Continuous Improvement Engineer to lead Lean initiatives... ...requires a Bachelor's in Industrial/Manufacturing/Mechanical Engineering and 4+ years in a medical device #J-18808-Ljbffr Penumbra, Inc.SeniorMedical device
$160k - $200k
...PRINCIPAL RESPONSIBILITIES We seek a hands-on regulatory leader to join Checkerspot Biosciences as Sr. Manager or Director of Regulatory Affairs. Checkerspot Biosciences licenses its... ...with NDINs; pharmaceutical or medical-device experience alone does not meet this requirement...SeniorMedical deviceContract workLocal area- ...Health, Inc. in Emeryville, CA, seeks a senior electrical engineer to join our core engineering... ...for digital stethoscopes, power our devices, and collaborate with mechanical,... ...contract manufacturers to ensure high yield, regulatory compliance, and robust field performance...SeniorMedical deviceContract work
- ...quality in a cross-functional setting. This onsite role requires a BS in engineering, 4+ years of related experience, and strong knowledge of regulatory design controls and GMP. Diabetes strips experience is a plus; standard shift with no travel. #J-18808-Ljbffr AbbottSeniorMedical deviceShift work
- Abbott Laboratories seeks a Senior Regulatory Affairs Specialist for Lingo in Alameda, CA. You will support regulatory activities for Class II software medical devices, collaborating with product teams to ensure compliant submissions and labeling throughout development...SeniorMedical device
- ...Diabetes Care in Alameda, CA is seeking a Senior Product Manager to lead strategy,... ...partner across hardware, software, and regulatory teams. The role requires 5+ years in product... ...-leaning degree, and healthcare/medical device domain experience. #J-18808-Ljbffr Thornton...SeniorMedical device
- ...statistical data, and collaborate with QC, Manufacturing, R&D, and Regulatory Affairs to ensure regulatory compliance and product quality. The... ...data integrity, and applying GMP/ICH guidance to analytical methods across medical devices and diagnostics. #J-18808-Ljbffr AbbottSeniorMedical device
- ...Complaint Handling, turning data into actionable post-market insights, and ensuring regulatory compliance. The candidate should have 5+ years in post-market surveillance within the medical device industry, with onsite presence in Alameda. 6-month duration and pay range of $5...SeniorMedical device
$37 - $43 per hour
Kelly® Science & Clinical is seeking a Senior Quality Control Analyst for a 4-6-month... ...pioneer progress in the biotechnology and medical device industries. Workplace: Emeryville, CA.... ...to junior QC analysts. Support regulatory inspections, client audits, and other quality...SeniorMedical deviceContract work- Abbott, based in Alameda, CA, seeks a Senior Counsel for Intellectual Property to lead worldwide patent strategy for the Diabetes Care business. You will coordinate internal teams and outside counsel to build robust IP assets and align filings with strategic goals. You...SeniorMedical deviceWorldwide
- ...professional for a 6-month contract in Alameda, CA, onsite only. This role focuses on independently handling complex medical device complaints, ensuring regulatory compliance, and driving data-driven improvements. Responsibilities include leading investigations, supporting...SeniorMedical deviceContract work
- Collabera is seeking a Senior Product Surveillance Analyst to support medical device complaint handling, post-market surveillance, and regulatory compliance. The role focuses on data analytics, trend identification, and quality metrics to support product safety and continuous...SeniorMedical device
$150k - $165k
...Senior Electrical Engineer We are seeking a Senior Electrical Engineer to lead electronic... ...hardware design efforts for wearable medical device products. The role will focus on PCB... ...electronics into products. Support regulatory and manufacturability reviews, DFM/DFT,...SeniorMedical deviceContract workWork at office- ...leadership role with autonomy, visibility, and direct access to senior executives and shareholders. If you are a hungry hunter,... ...new opportunities across biotech, mid‑pharma, Big Pharma, and medical device sponsors. Expand strategic accounts, building trusted...SeniorMedical deviceContract workImmediate start
- As a Senior Supplier Quality & Compliance Analyst, you will engage in the management... ...developing criteria, ensuring alignment with regulatory standards, and collaborating with... ...trends related to quality compliance in the medical device industry. Responsible for timely...SeniorMedical device
- ...or low-volume production. A bachelor’s degree in a relevant engineering field or equivalent practical experience is required; medical-device, regulated-environment, DFM, design-transfer, and IQ/OQ/PQ experience are preferred. Key Skills Mechanical Design, CAD, Fixture...SeniorMedical deviceWork at office
$37 - $43 per hour
Kelly® Science & Clinical is seeking a Senior Quality Control Analyst for a 4-6-month... ...pioneer progress in the biotechnology and medical device industries. Workplace: Emeryville, CA.... ...to junior QC analysts. Support regulatory inspections, client audits, and other quality...SeniorMedical deviceContract workTemporary workLocal area- ...Senior Sales Operations AnalystAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our... ...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000...SeniorMedical deviceWork at office
$148.7k - $297.3k
...towards the future, anticipating changes in medical science and technology. Working at... ...track and analyze glucose levels. As a Senior Manager, Forecasting and Strategy, you will... ...communication skills Experience in medical devices and/or biopharma industry. Deep...SeniorMedical deviceTemporary workWorldwide$168k - $238k
...Experience: 5+ years of commercial operations consulting or direct commercial operations experience in the biotech, pharmaceutical, or medical device industries. 2+ years of oncology experience is strongly preferred. Oral specialty drug experience is strongly preferred....SeniorMedical deviceWork at officeLocal areaFlexible hours$155k - $165k
...Our Company Koya Medical, a privately held company... ...Job Summary The Senior Electrical Engineer... ...while supporting medical device quality, reliability,... ..., and regulatory expectations. This... ...position will report to the Director, Computer and Electrical...SeniorMedical deviceFull timeContract work$130k - $150k
Senior Biomedical Engineer Position Overview We are... ...invasive therapeutic devices with a focus on catheter... ..., validation, regulatory submission, and design... ...building revolutionary medical device products. This... ...interact with regulatory affairs to support FDA submissions...SeniorMedical device$125k - $150k
...0,000.00 USD Annually Description: Senior Biomedical Engineer Location: Oakland... ...the Opportunity A privately held medical device company developing innovative treatments... ...prototyping, testing, design controls, regulatory documentation, suppliers, and manufacturing...SeniorMedical deviceContract workWork at office$114k - $228k
...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000... ...resource on product development teams, working with R&D, Regulatory Affairs, Quality Assurance and Marketing in identifying user needs...SeniorMedical deviceWork experience placementShift work
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