Global Regulatory Affairs Associate - Medical Devices
Penumbra Inc
Penumbra, Inc. is seeking a regulatory professional to coordinate, prepare, and maintain document packages for worldwide regulatory submissions. Under supervision, you will assist in preparing diverse submissions (510(k), CE Mark, UKCA, IDE) and track multiple projects to ensure timely approvals. You will support labeling reviews, regulatory intelligence research, and collaboration with in-country personnel to facilitate global clearance. #J-18808-Ljbffr Penumbra
$77k - $98k
...maintenance of document packages for worldwide regulatory submissions. What You’ll Work On Under... ...in-country RA personnel to facilitate global clearance/approvals. Research and... ...or demonstrated experience Regulatory Medical Device experience preferred Proven ability to...Medical deviceTemporary workWork at officeLocal areaWorldwide- Job Title: Regulatory Affairs Associate Location: Alameda CA Duration: 10+ months The Opportunity As an... ...experience in a regulated industry (e.g., medical products, nutritionals, pharma, food)... ...or Quality experience within Medical Devices is preferred. Experience with review...Medical deviceWork experience placementWork at officeWorldwide
$140k - $185k
...and most serious unmet medical needs. We work to... ...treatment options, creating devices aimed at restoring... ...Foundry. The Senior Regulatory Specialist will serve... ...Quality and Regulatory Affairs team, where each team... ...This role will drive global regulatory strategies...Medical deviceFull timeLocal areaRemote workFlexible hours$90k - $180k
## Senior Regulatory Affairs Specialist - Lingo (on-site)Applylocations: United States - California... ...requisition id: 31151543Abbott is a global healthcare leader that helps people... ...businesses and products in diagnostics, medical devices, nutritionals and branded generic...Medical deviceShift work$100k - $200k
## Principle Regulatory Affairs Specialist - Diabetes Care (on-site)Applylocations... ...id: 31151822Abbott is a global healthcare leader that... ...products in diagnostics, medical devices, nutritionals and branded... ...agencies and trade associations, develop innovative regulatory...Medical deviceWorldwideShift work$100k - $200k
Abbott is a global healthcare leader that helps people live more... ...products in diagnostics, medical devices, nutritionals and branded generic... ...**Principal International Regulatory Operations Specialist** will... ...as RAC from the Regulatory Affairs Professionals Society.)* 2-3...Medical deviceWorldwide- Pulse Biosciences, Inc. is seeking a Principal Global Regulatory Affairs Specialist in Hayward, CA. The role leads global regulatory strategies for general, cardiac, and dermatology medical devices, coordinating with cross-functional teams and regulatory authorities. You...Medical device
- Pulse Biosciences is seeking a Principal Global Regulatory Affairs Specialist in Hayward, CA (onsite). You will drive global regulatory strategy for general, cardiac, and dermatology medical devices, coordinating submissions to FDA and EU authorities and ensuring compliance...Medical device
- Spectraforce Technologies, Inc. seeks a Regulatory Affairs Associate in Alameda, CA for a 10+ month assignment. You will support Regulatory Affairs to ensure compliant business processes and may work with multiple functions. You’ll review labeling, advertising and promotional...
$148.7k - $297.3k
About Abbott Abbott is a global healthcare leader that helps people live more... ...and products in diagnostics, medical devices, nutritionals and branded generic... ...scientists. The Opportunity This Associate Director Regulatory Affairs will work on-site out of our Alameda...Medical deviceWorldwideShift work$113k - $150k
...developing criteria, ensuring alignment with regulatory standards, and collaborating with... ...trends related to quality compliance in the medical device industry. • Responsible for timely... ...in Alameda, California, is a global healthcare company focused on innovative...Medical deviceTemporary workWork at officeLocal area$100k - $200k
Abbott Laboratories is seeking a Principal International Regulatory Operations Specialist to join its Diabetes Care Division. The role... ...discipline, experience with regulatory submissions for medical devices or pharmaceuticals, and excellent communication skills. The...Medical device$108.5k - $151.3k
...Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.... ...Engineering or a related discipline, with 4+ years of experience in the medical device or related industry, or an equivalent combination of education...Medical deviceTemporary workLocal area$77k - $98k
...Regulatory Affairs Specialist I at Penumbra will coordinate and prepare regulatory submission documentation for medical device approvals across global markets. The role involves supporting worldwide regulatory submissions, maintaining compliance documentation, and collaborating...Medical deviceWork at officeWorldwide- ...Company Stark Pharma Solutions Inc. is a global consulting and staffing partner... ...in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the... ...solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project...Medical device
$109k - $152k
...abilities, and to support the efforts and projects that have global importance to the success of the business. Area of work involves... ...experience in a manufacturing environment recommended, medical device industry preferred Excellent written, verbal, and interpersonal...Medical deviceTemporary workWork at officeLocal area- ...Job Description Job Description Job Title: Sr. Regulatory Specialist Duration: 6 Months Contract (Possibility of Extension... ...Job Description: Must have 7 years of experience in Medical Device Regulatory Affairs. Highly experienced in regulatory change assessments....Medical deviceContract workShift work
$85k - $95k
...company that specializes in the development of innovative solutions for the automated reprocessing of reusable medical devices. Today, Nanosonics has a global presence with offices across Australia, Canada, the United States of America, Europe, the United Kingdom and...Medical deviceFull timeLocal areaRemote work- ...for the pharmaceutical, biotechnology, medical device, and life sciences industries. As the pioneer... ...medical device R&D, manufacturing, and regulatory processes and environments. Existing... ...Work directly with leading global pharmaceutical, biotechnology, and medical...Medical deviceContract workRemote work
- 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...Medical device
- ...and sensor interfaces, while collaborating with firmware, algorithms, and quality teams in a hands‑on lab environment. You’ll lead root cause analysis, work with contract manufacturers, and contribute to regulatory and DFMEA processes for医疗 devices. #J-18808-Ljbffr EkoMedical deviceContract work
- ...integration, and debugging. You will lead verification, reliability, and manufacturability improvements as research prototypes move toward production‑intent Class III medical devices, coordinating technical decisions and documentation across teams. #J-18808-Ljbffr Epia NeuroMedical device
- ...development teams to design and qualify new life-saving products. You will help develop quality system elements to ensure high quality and regulatory compliance, and help bring products safely and efficiently to market. The role involves developing testing methodologies, quality...Medical device
$150k - $220k
...outcomes, and move fast without cutting quality corners. Preferred qualifications Experience in aerospace, defense, robotics, medical device or autonomy hardware. Background building a supply chain function at an early-stage startup or a new factory. Established network...Medical deviceFull timeContract workWork at office$90k - $180k
...Abbott is a global healthcare leader that helps people live more... ...products in diagnostics, medical devices, nutritionals and branded generic... ...with applicable medical regulatory standards. Troubleshoots... ...protocols/reports and other associated documentation following design...Medical deviceWork experience placementWorldwideShift work- ...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,...Medical device
- Medical Device & Biotech is seeking an Entry Level Lab Technician to join the Complaint Investigations Lab, supporting complaint investigations... ...habits, and willingness to learn hands-on troubleshooting and lab testing procedures. #J-18808-Ljbffr ManpowerGroup Global Inc.Medical deviceContract workShift work
- 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 ...Medical device
- ...with data-driven performance metrics, while collaborating with manufacturing, quality, and R&D to implement improvements. The role requires a Bachelor's in Industrial/Manufacturing/Mechanical Engineering and 4+ years in a medical device #J-18808-Ljbffr Penumbra, Inc.Medical device
- 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...Medical device
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