Regulatory Affairs Manager, Medical Devices
Noctrix-Health
Noctrix Health in Pleasanton, CA seeks an experienced Manager, Regulatory Affairs to lead regulatory activities for medical devices across development, registrations, and post-market compliance. Hybrid, full-time role reporting to Senior VP Clinical & Regulatory Affairs, based at our Pleasanton headquarters. The ideal candidate will manage FDA submissions (510(k) and international registrations), maintain registrations, review labeling, and coordinate cross-functional teams to ensure timely, #J-18808-Ljbffr Noctrix-Health
$114k - $228k
...PleasantonJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted... ...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...Opportunity We are seeking a Regulatory Affairs Manager to join Abbott’s Heart Failure Division...Medical deviceWorldwide- ...clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers... .... We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the...Medical deviceFull time
- Noctrix Health, Inc. is seeking a Manager, Regulatory Affairs to lead regulatory strategies for our wearable medical devices, based in Pleasanton, CA. You will drive submissions, registrations, and cross‑functional compliance throughout the product lifecycle. Ideal candidates...Medical device
- Noctrix Health, based in Pleasanton, CA, seeks a Manager, Regulatory Affairs to lead regulatory programs for medical devices, including FDA submissions, registrations, and post‑market compliance. This is a hybrid, full‑time role at our Pleasanton headquarters. The ideal...Medical deviceFull time
- Noctrix Health, based in Pleasanton, CA, seeks an experienced Manager, Regulatory Affairs to lead regulatory activities for medical devices throughout the product lifecycle. This hybrid role involves coordinating with Clinical Affairs, Quality, Engineering, and external...Medical device
- Noctrix Health in Pleasanton is seeking a Manager, Regulatory Affairs to lead global regulatory strategy for medical devices, oversee submissions, and ensure post-market compliance across markets. You will partner with Clinical Affairs, Quality, Engineering, Operations...Medical device
- ...position (includes testing for use of marijuana)Medical Exam: A job-related pre-placement medical... ...an opening for a Document Compliance Manager to support the document control and... ...with the use and/or possession of mobile devices in Limited Areas. Depending on your job duties...Medical deviceFull timeFor contractorsWork at officeRelocationFlexible hours
$129.15k - $163.76k
...testing for use of marijuana)Medical Exam: Not applicable Company... ...Davis-Bacon Act (DBA) Compliance Manager. You will provide technical... ...technical performance and regulatory compliance requirements/problems... ...and/or possession of mobile devices in Limited Areas. Depending...Medical deviceFull timeContract workFor contractorsFor subcontractorWork at officeWork from homeRelocationFlexible hours1 day per week$172k - $344k
...and products in diagnostics, medical devices, nutritionals and branded... ...Director, Quality Systems & Regulatory is a key leadership role responsible... ...Systems and Regulatory Affairs activities across ACH,... ...with Operations, Revenue Cycle Management, Finance, Commercial, Legal,...Medical deviceWork at officeShift work- ...Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing... ...validation (IQ/OQ/PQ), configuration management, and continuous process improvement.... ...ensuring compliance with quality and regulatory standards.Strong background in cross-...Medical device
$90k - $180k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...developing solutions to diagnose, monitor and manage heart failure, allowing people to... ...teams for concept feasibility and formal regulatory submission Contribute to the continuous...Medical deviceFor contractorsRemote workWorldwide- ...Co-op/Intern will support sustaining and new product activities on-site, with a minimum of 20 hours per week for the duration of the program. This role offers exposure to medical device engineering in a collaborative environment. #J-18808-Ljbffr AtriCure Co-op/InternMedical deviceInternship
$230k
...acute treatment of serious medical conditions—where rapid therapeutic... ...are treated. Job Summary Manage all regulatory activities for the company.... ...pharmaceutical and medical devices. Ability to work with partners... ...with direct regulatory affairs experience with drug products...Medical device$120k - $140k
...testing and ensure best practices in clinical applications. This role requires a BS in Engineering, with at least 5 years in the medical device industry, and offers a competitive salary of $120,000 - $140,000, along with a diverse work environment and various employee...Medical device- ...The role leads system-level integration across hardware, embedded software, mobile apps, wireless tech, and cloud services to meet regulatory requirements and product goals. The candidate will work with Systems, Software, Hardware, Quality, Clinical, and Regulatory teams...Medical device
$101.2k - $126.5k
...Industrial Quality & Research, Medical Technology, Consumer... ...seeking a Planning Manager who is also qualified... ...(DR) to oversee regulatory licensing and ensure full... ...prescription medical devices within licensed facilities... ...with Regulatory Affairs to apply for, maintain...Medical deviceFull timeWork experience placementLocal area$120k - $140k
...development for kidney stone treatment. The ideal candidate will have a strong background in clinical engineering and experience in medical device testing. With a competitive salary range of $120,000 - $140,000, this role includes opportunities for growth, stock options,...Medical device- ...offerings in the field of kidney stone treatment. Applicants should possess a relevant degree with extensive experience in the medical device industry, focusing on clinical engineering activities. The role requires excellent interpersonal and negotiation skills, along...Medical deviceWork at office
- ZEISS in Dublin, CA is seeking a Planning Manager who also serves as a California-... ...Designated Representative (DR) to oversee regulatory licensing and ensure compliance with FDA... ...wholesale distribution of prescription medical devices and drugs. The role combines regulatory...Medical device
- ...best-practice quality tools, support design reviews and ensure compliance with ISO 13485 and FDA 21 CFR 820. Partner with R&D, Regulatory Affairs and Operations to drive design verification/validation, risk analyses, and control plans, while maintaining DHFs and CAPA...Medical device
- Experis is seeking an Engineer, Design Assurance in Pleasanton, CA for a 6-month on-site assignment in the medical device industry. You will support Risk Management and Product Development within the Quality Systems Department, focusing on ISO 14971 guidelines and design...Medical device
- ...Solutions Inc is seeking an experienced Systems Engineer based in Pleasanton, CA. You will lead system integration for complex medical devices, focusing on the integration of hardware and software. The ideal candidate has a strong background in systems engineering and experience...Medical device
- A leading medical device company in California is seeking an experienced professional to lead Quality Assurance and Regulatory Affairs teams. This role requires 15+ years of experience in medical... .... The successful candidate will manage compliance with FDA regulations and...Medical device
- ...is seeking a Lead Design Assurance Engineer to drive risk management activities for medical device development. You will own risk management files, work with Engineering, Marketing, Manufacturing and Regulatory, and ensure design controls and V&V are integrated throughout...Medical device
- ...sustaining changes, and manufacturing updates. The role partners with Regulatory, Engineering, Operations, and external partners to ensure... ...position demands deep FDA Design Control, ISO 13485, and risk management expertise, with a focus on mentor- ing teams, robust #J-18808...Medical device
- ...issues today and address the medical challenges of tomorrow. We strive... ...Quality Engineer, Medical Device External Quality is part of... ...group and reports to the Senior Manager, Medical Device External... ...with defined specifications and regulatory requirements. Responsibilities...Medical deviceFull timeContract workTemporary workLocal area
- ...client, a leading organization in the medical device industry, is seeking an Engineer, Design... ...Systems Department supporting Risk Management and Product Development teams. The ideal... ..., Marketing, Manufacturing, and Regulatory teams to establish comprehensive risk...Medical deviceTemporary workFlexible hoursShift work
- ...validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and... ...Research, Engineering, Quality, Regulatory Affairs, and Product teams to generate clinical... ...Affairs, Quality Assurance, Product Management, and Engineering to advance safe, effective...Medical deviceFull timeWork at office3 days per week
- Job-ID32276842Reference26-00617 Roles & Responsibilities: 5 to 6 years of Medical Device Supplier Quality experience with Electrical background. Candidates with IPC certifications & Expertise in PCBA inspections. Experience in Interacting with US & Overseas supplier Experience...Medical deviceOverseas
- Abbott Laboratories in Pleasanton, CA is seeking a Project Manager to serve as a liaison between project owners, teams, and senior management... .... You will drive process improvements across R&D, Operations, Regulatory, Quality and Commercial functions. The role requires 6+ years...Medical device
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