Director of Clinical Affairs, Medical Devices
Noctrix-Health
Noctrix Health in Pleasanton, CA is seeking a Director, Clinical Affairs to lead planning, execution, and oversight of clinical studies supporting regulatory approval and reimbursement of our wearable medical devices. This role partners across Clinical Affairs, Regulatory, Quality, Product Development, and external partners to ensure studies are conducted per FDA/ICH-GCP/ISO14155, on budget and schedule, delivering high-quality evidence for submissions and market access. #J-18808-Ljbffr Noctrix-Health
- Abbott is seeking a Regulatory Affairs Specialist for the Pleasanton, CA area to support the Heart Failure division. As an individual... ...across functions to maintain approvals and licensing for medical devices. You will interact with regulatory agencies, ensure compliance...Medical device
- Abbott Laboratories in Pleasanton, CA is seeking a Regulatory Affairs Specialist to support regulatory activities and product registrations across the Heart Failure division. This role partners with cross-functional teams and works with limited supervision to ensure timely...Medical device
- ...Pleasanton, CA seeks an experienced Manager, Regulatory Affairs to lead regulatory activities for medical devices across development, registrations, and post-market... .... Hybrid, full-time role reporting to Senior VP Clinical & Regulatory Affairs, based at our Pleasanton...Medical deviceFull time
- ...Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to lead regulatory... ...commercialization of category-defining medical devices. You will own U.S. and international submissions... ...partner with R&D, Operations, Quality, Clinical, and Legal to align regulatory...Medical device
$114k - $228k
...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... ...guidelines of the regulatory profession, clinical research and regulatory processCommunication...Medical deviceWorldwide$90k - $180k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...of their health by delivering seamless clinical solutions from diagnosis to monitoring... ...are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in...Medical deviceFor contractorsWorldwide$240k - $280k
...treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer... ...are seeking an experienced and strategic Director, Clinical Affairs to lead the planning, execution, and...Medical deviceFull time- Noctrix Health, Inc. is seeking a strategic Director of Clinical Affairs to lead planning, execution, and oversight of clinical studies for our drug-free wearable therapy. You will drive evidence generation to support regulatory submissions, reimbursement, and commercialization...
$150k - $180k
...treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer... ...experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities...Medical deviceFull timeFor contractorsFor subcontractor$73.9k - $116k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...of their health by delivering seamless clinical solutions from diagnosis tomonitoringand... ...treatment. The Opportunity This Regulatory Affairs Specialist will work out of our Pleasanton...Medical deviceWork experience placementShift work- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications with regulatory agencies, and ensuring compliance with evolving regulations...Medical device
- Calyxo, Inc. is a medical device company headquartered in Pleasanton, California... ...Senior Regulatory Affairs Specialist to support our growing... ..., Operations, Quality, Clinical and Medical Affairs, Marketing... .... Who You Will Report To Director, Regulatory Affairs Requirements...Medical deviceWork at officeWorldwideShift work
- ...investigators and engineers responsible for post-market surveillance and root-cause analysis of complaints. You will partner across Medical Affairs, Regulatory, Operations, R&D and Customer Service to ensure timely, compliant investigations, maintain documentation per FDA/...Medical device
- NoctrixHealth in Pleasanton, CA is seeking a Clinical Research Engineer to bridge engineering... ...and validation of wearable medical devices. You will collaborate with Clinical Research... ...Research, Engineering, Quality, Regulatory Affairs, and Product teams, reporting to the...Medical device
- ...Overview We are partnering with a growing, innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy,... ...field actions Partner closely with R&D, Quality, Clinical, and Commercial teams Qualifications 8+ years of...Medical deviceLocal area
- A leading medical device company is seeking a Product Manager in Pleasanton, CA. This hybrid role involves managing the product lifecycle from conception to commercialization, requiring experience in the spine sector. Responsibilities include market analysis, product development...Medical device
- ...Medical Device AssemblerThe medical device assembler is responsible for producing high-quality medical devices within a manufacturing cell under close supervision. This role may include assembly, repair, and testing of pacemakers, implantable cardioverter defibrillators...Medical device
$130k - $150k
...clinicallyvalidatedtherapeutic wearables. Our team of medical device specialists, neuroscientists, and... ...’s first drug-free wearable therapy, clinically proven to alleviate symptoms in adults... ..., Engineering, Quality, Regulatory Affairs, and Product teams to generate clinical...Medical deviceFull timeWork at office3 days per week$230k
...Pharmaceutical Holdings Limited , is a clinical-stage biotechnology company... ...acute treatment of serious medical conditions—where rapid... ...both pharmaceutical and medical devices. Ability to work with... ...industry with direct regulatory affairs experience with drug products...Medical device$330k
...The VP, Quality & Regulatory Affairs is an executive leadership role... ...across product development, clinical manufacturing, and commercial... ...affairs experience with drug/device combination products.... ...GMP-regulated pharmaceuticals, medical devices or drug combination products...Medical device- ...compliance with FDA MDR and device vigilance reporting regulations... ...strategies. Regulatory Affairs: Lead and develop a Regulatory... ...information about Moximed’s applicable clinical trials (ACT) on... ...timely processing of Moximed Medical Device Reports (MDRs) in accordance...Medical deviceFlexible hours
$170k - $225k
...operations, Lean ManufacturingPosition OverviewA rapidly growing precision manufacturing company serving the aerospace, defense, medical device, and space industries is seeking an experienced General Manager to lead a high-performance manufacturing operation.This is a...Medical device- Job-ID32323536Reference26-00701 Job Summary:Manufacturing Engineer with 3-4 years of experience in the medical device manufacturing industry, specializing in supporting regulated production environments. Experienced in manufacturing operations, process validation (IQ/OQ...Medical device
- ...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
- ...Director Medical & Scientific Affairs - Cardiovascular Imaging ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment... ...solutions that support drug, device and diagnostic development....Medical deviceLive inRemote workWorldwideFlexible hours
$90k - $180k
...portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.Job Title Senior Electrical...Medical deviceFor contractorsRemote workWorldwide$120k - $140k
Calyxo is seeking a Clinical Development Engineer in Pleasanton, CA, to provide clinical insights and support new product development... ...strong background in clinical engineering and experience in medical device testing. With a competitive salary range of $120,000 - $140,0...Medical device- ...readiness. You will collaborate across Quality, Regulatory Affairs, Clinical Affairs, Engineering, Operations, and Manufacturing to streamline... ...workflows, support audits, and drive continuous improvement in our FDA-regulated medical device #J-18808-Ljbffr Noctrix Health, Inc.Medical deviceRemote job
$34.58 - $38.91 per hour
...patient care, encompassing activities such as device monitor scheduling, processing,... ...Procedure Assistance: Prep and assist with in-clinic procedures, and coordinate procedures... ...weight logs, and other health tracking for medication management. Insurance Authorizations:...Medical deviceHourly pay- ...architect, validate, and own the system-level behavior of a complex medical device ecosystem across the product lifecycle. You will define the... ...to coordinate hardware, software, disposables, and clinical use environments while ensuring robust #J-18808-Ljbffr CalyxoMedical device
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