Hybrid Senior Regulatory Strategist Medical Devices
BBG Ventures, LLC
BBG Ventures, LLC is seeking a Senior Regulatory Affairs Specialist to join their team in Sunnyvale, CA on a hybrid basis (3 days on-site, 2 days remote). The ideal candidate will have a minimum of 8 years of regulatory affairs experience in the medical device sector and a strong understanding of U.S. regulations. This role involves providing regulatory guidance, preparing submissions, and ensuring compliance with industry standards. The position offers competitive contractor benefits and a chance to work in a dynamic environment focused on innovative surgical solutions. #J-18808-Ljbffr BBG Ventures, LLC
- System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, CA, to lead regulatory strategy and submissions for medical devices across the U.S., Canada, and global markets. This... ...international teams to support global approvals. Hybrid work with onsite days is offered. #J...SeniorRegulatoryMedical deviceContract work
- ...open approach. Working with top medical professionals, they continue to... ...challenges worldwide. Position Senior Regulatory Affairs Specialist (Contract Basis) - Hybrid (3 days on‑site, 2 days remote per... ...affairs experience in a medical device environment. Strong understanding...SeniorRegulatoryMedical deviceContract workFor contractorsRemote workWorldwide2 days per week
$149k - $192k
About CeribellCeribell is a medical technology company focused on... ...features into product offerings. Regulatory and Compliance Leadership:... ...AI and Software as a Medical Device (SaMD). Neurodiagnostics Expertise... ...updates for Ceribell’s senior leadership, ensuring alignment...SeniorRegulatoryMedical deviceLocal area- Intuit seeks a Principal Regulatory Compliance Manager to lead the company’s money transmission and regulatory product compliance program in a hybrid role. You will serve as a senior technical authority, partnering with product, engineering, legal, and business functions...SeniorRegulatory
- ...California is looking for a Principal Regulatory Affairs Specialist to... ...strategies for Class III devices. This role involves authoring... ...submissions, ensuring compliance for medical devices, and mentoring junior... .... The position offers a hybrid work culture, allowing flexibility...SeniorRegulatoryMedical device
- ...Senior Systems EngineerDeepSight Technology Inc. is an early-stage, pre-commercial medical device company with a vision for Physical AI -scaling advanced... ...robust, traceable, and regulatory-compliant test solutions.... ...working in Agile or hybrid development environments...SeniorRegulatoryMedical device
- ...software development initiatives in the medical device and robotics sectors. Candidates should... ...a related field, and familiarity with regulatory requirements. This role offers opportunities... ...contribution in a dynamic environment. #J-18808-Ljbffr Cloud Hybrid Technologies LLCSeniorRegulatoryMedical device
$180k - $200k
...Senior Quality EngineerMountain View, CAWillow is a... ...of Willow Innovations medical breast pump products and... ...manufacturing, quality, regulatory, and clinical affairs efforts... ...10 years in medical device quality engineering... ...interactions. This is a hybrid role based in Mountain...SeniorRegulatoryMedical device$272k - $336k
...about driving results.This role follows a hybrid work schedule and you will report... ...(scalable) strategy for (technical but regulatory) evidence generation.Drive the implementation... ...driving (ADS), aerospace, robotics, or medical device industriesExperience successfully...SeniorRegulatoryMedical deviceOdd jobFull timeRemote work$150k - $165k
About CeribellCeribell is a medical technology company focused on... ...participating in DFX.This role is hybrid and requires 3-5 days in our... .../wearable electromechanical devices.Experience with... ...assembly (PCBAs, Flex Cables, etc)Regulatory Competency: Demonstrated ability...SeniorRegulatoryMedical deviceLocal areaFlexible hours- ...IntelliPro in Sunnyvale, CA is seeking a Regulatory Affairs Specialist 4 for a 6+ month engagement. You will develop regulatory plans... ...and Health Canada filings. The ideal candidate has 8+ years in medical device regulatory affairs, deep knowledge of US, Canada and EU MDR,...SeniorRegulatoryMedical device
- Job Summary: Seeking a Senior Medical Device Quality & Compliance Engineer with expertise in Medical Device Quality Systems, Regulatory Compliance, Design Transfer, Risk Management, and Quality Engineering. The ideal candidate will support surgical robotics platforms,...SeniorRegulatoryMedical device
- Abbott seeks a Principal Regulatory Affairs Specialist to provide regulatory leadership for endovascular medical devices in Santa Clara, CA or Temecula, CA. You will manage regulatory activities across U.S., EU, and other markets, supporting lifecycle management and global...SeniorRegulatoryMedical device
- Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for the Vascular division, working on-site in Santa Clara,... ...development through commercialization. The role requires 6-8 years in medical devices, experience with Class II/III devices, and strong...SeniorRegulatoryMedical device
- System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, California to lead regulatory strategy and submissions for medical devices across the U.S., Canada, and global markets. You will support product development, design changes, lifecycle management, and...SeniorRegulatoryMedical device
- Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Senior Regulatory Affairs Specialist to lead regulatory plans, assess design-change impacts, and prepare regulatory submissions for the U.S., Canada, and international markets. You will collaborate...SeniorRegulatoryMedical device
- ...clinical evaluations for new product features and trials. The position emphasizes collaboration across regulatory, human factors, training, and product management, with a focus on translating clinical needs into validated, safe medical devices. #J-18808-Ljbffr Socket.devSeniorRegulatoryMedical device
- Intuitive in Sunnyvale, CA seeks an experienced Regulatory Affairs professional to provide expert leadership in global submissions and compliance strategy. The role focuses on cross-functional coordination, technical documentation, and agency interactions to support product...SeniorRegulatoryMedical deviceWorldwide
- ...DescriptionPrimary Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-... ...compensation ranges are listed.SummaryType: Full-timeFunction: Quality AssuranceExperience level: AssociateIndustry: Medical DeviceSeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
$101k - $148.55k
Baker Tilly Advisory Group, LP is seeking a Tax Senior Associate for a hybrid role in Santa Clara, CA. The candidate will execute corporate, partnership... ..., and estate tax engagements with focus on accuracy and regulatory compliance. This role requires strong technical tax...SeniorRegulatory$120k - $140k
...120,000-$140,000 a yearRoles and Responsibilities:Must Have Technical/Functional Skills:Strong understanding of Medical Device Quality Systems and regulatory compliance requirementsWorking knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation...SeniorRegulatoryMedical deviceFull time- ...Senior Systems EngineerThis Senior Systems Engineer will be part of the System Development team... ...development lifecycle to develop and maintain medical device products, according to customer requirements, applicable regulatory and quality standards. This role is expected...SeniorRegulatoryMedical device
- ...Building Bio in Sunnyvale, CA is seeking a Senior Manufacturing Quality Engineer to advance TMV capabilities for catheter-based medical devices. You will work with the Manufacturing... ...fixturing, and experience with QMS and regulatory standards. #J-18808-Ljbffr Women...SeniorRegulatoryMedical device
- Johnson & Johnson is seeking a Senior Quality Compliance Engineer- Shockwave Medical to join our Santa Clara, CA team. The... ...and calibration programs meet regulatory standards. The candidate will coordinate... ...the QMS in a fast-paced medical device environment. #J-18808-Ljbffr 694...SeniorRegulatoryMedical device
- ...portfolio. You will translate clinical insights into robust requirements and work across engineering, clinical, regulatory, and human factors teams. Ideal candidates have 8+ years in medical devices and at least 4 years in a medical device role, with #J-18808-Ljbffr IntuitiveSeniorRegulatoryMedical deviceFull time
- Abbott Laboratories is seeking a Senior Project Manager/Clinical Evaluation Reporting to lead CER activities for medical devices on-site in Santa Clara, Pleasanton, Atlanta, or... ...Clinical Evaluation Reports, and support regulatory submissions under EU MDR 2017/745,...SeniorRegulatoryMedical device
- Intuitive in Sunnyvale, CA is seeking a senior Product Manager for Ion Endoluminal to... .... Collaborate with R&D, manufacturing, regulatory, and commercial teams to meet clinical... ...The role requires at least 5 years in medical device PM/marketing, excellent analytical and...SeniorRegulatoryMedical device
- ...Function of the PositionThe Senior Clinical Development Engineer... ...the surgical environment and medical technology to work with design... ...efficacy of new productsSupport regulatory documentation and submissions... ...of experience in medical device industry with a Bachelor’s degree...SeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- ...DescriptionPrimary Function of the PositionThe Digital Senior Clinical Development Engineer... ...data science, human factors, product, regulatory, and quality teams to define... ...ExperienceMinimum of 8 years of experience in medical device industry with a Bachelor’s degree, 6...SeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- Cordance Medical is seeking a Mechanical Engineer to support its engineering team during... ...critical phase of product development aimed at regulatory submission. The role suits engineers... ...and exposure to all aspects of medical device development at an early‑stage startup....RegulatoryMedical device
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