Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Affairs Leader - Medical Devices (Hybrid)

System One

System One is seeking a Sr. Regulatory Affairs Specialist in Sunnyvale, CA for a contract role with a hybrid work model. The candidate must have a BS degree and at least 8 years of regulatory affairs experience in medical devices. The role includes leading regulatory plans, preparing submissions (FDA 510(k), Health Canada), and aligning global strategies. Strong communication and collaboration skills are essential. #J-18808-Ljbffr System One

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Leader - Medical Devices (Hybrid) in Sunnyvale, CA vacancy
  • 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... 
    Senior
    Medical device
    Contract work

    System One

    Mountain View, CA
    17 hours ago
  • System One is seeking a Sr. Regulatory Affairs Specialist in Sunnyvale, CA. The role requires a BS degree and at least 8 years of Regulatory Affairs experience in medical devices. You will lead regulatory plans, prepare FDA 510(k) submissions, and guide product teams on... 
    Senior
    Medical device

    System One

    Mountain View, CA
    17 hours ago
  • 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...  ...of regulatory affairs experience in the medical device sector and a strong understanding of U.S.... 
    Senior
    Medical device
    For contractors
    Remote work

    BBG Ventures, LLC

    Sunnyvale, CA
    4 days ago
  •  ...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... 
    Senior
    Medical device
    Contract work
    For contractors
    Remote work
    Worldwide
    2 days per week

    BBG Ventures, LLC

    Sunnyvale, CA
    17 hours ago
  • 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... 
    Senior
    Medical device

    Abbott

    Santa Clara, CA
    3 days ago
  • 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... 
    Senior
    Medical device

    Intuitive Surgical, Inc. in

    Sunnyvale, CA
    2 days ago
  • Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for the Vascular division, working on-site in Santa Clara, CA...  ...through commercialization. The role requires 6-8 years in medical devices, experience with Class II/III devices, and strong collaboration... 
    Senior
    Medical device

    Abbott Laboratories

    Santa Clara, CA
    3 days ago
  • 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... 
    Senior
    Medical device
    Worldwide

    Intuitive

    Sunnyvale, CA
    4 days ago
  •  ...LegalZoom is seeking a Senior Market Research Manager to join the Product Marketing team. You will lead market research programs, partner...  ..., and ability to influence decisions across the organization. Hybrid work model with offices in Mountain View and other locations; remote... 
    Senior
    Remote work

    LegalZoom

    Mountain View, CA
    22 hours ago
  •  ...is looking for a Principal Regulatory Affairs Specialist to spearhead complex...  ...strategies for Class III devices. This role involves authoring...  ...submissions, ensuring compliance for medical devices, and mentoring...  .... The position offers a hybrid work culture, allowing flexibility... 
    Senior
    Medical device

    Real

    Sunnyvale, CA
    17 hours ago
  •  ...hiring a Sr. Manager, Product Security - Shockwave Medical to join our team in Santa Clara, CA. You will...  ...patterns and controls for medical devices. You will collaborate with engineering, quality, PMO, and regulatory to translate global cybersecurity expectations... 
    Senior
    Medical device

    Shockwave Medical

    Santa Clara, CA
    2 days ago
  • Intuitive Surgical, Inc. in Sunnyvale, CA, seeks a Senior Quality Engineer to oversee end-to-end quality investigations across manufacturing...  ...design activities. You will lead CAPA, risk assessment, and regulatory readiness, mentoring junior engineers and ensuring GMP/ISO/FDA... 
    Senior
    Medical device

    Intuitive Surgical, Inc.

    Sunnyvale, CA
    1 day ago
  •  ...role demands 5+ years of sourcing experience, particularly for senior technology roles, and involves cultivating candidate networks and...  ...employer brand. Located in Mountain View, CA, this position offers a hybrid work environment with a focus on innovation and diversity in... 
    Senior
    Contract work

    Prospance Inc

    Mountain View, CA
    2 days ago
  •  ...to optimize logistics and ensure compliance. The role requires 4-6+ years in logistics, knowledge of freight carriers, SAP ERP, and strong Excel/reporting skills. Hybrid/remote work options may be available; local candidates encouraged to apply. #J-18808-Ljbffr Belden
    Senior
    Local area
    Remote work

    Belden

    Sunnyvale, CA
    2 days ago
  •  ...Cupertino, California is seeking a Principal Regulatory Affairs Associate for their health products...  ...to obtain approvals for innovative medical devices, requiring 10+ years of medical device...  ...filings, and participate in a hybrid work environment. Join Apple to impact... 
    Medical device

    Apple Inc.

    Cupertino, CA
    3 days ago
  • 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... 
    Senior
    Medical device

    System One

    Sunnyvale, CA
    3 days ago
  •  ...do at Intuitive. As a global leader in robotic-assisted surgery...  ...provides expert support for regulatory project management, strategic...  ...Mentor and coach regulatory affairs specialists. • Track and...  ...timeFunction: Quality AssuranceExperience level: AssociateIndustry: Medical Device
    Senior
    Medical device
    Local area
    Worldwide
    Flexible hours

    Intuitive Surgical

    Sunnyvale, CA
    2 days ago
  •  ...leading health technology firm is seeking a Regulatory Affairs Specialist to manage regulatory...  ...compliance activities for innovative medical devices. The ideal candidate will have a Bachelor...  ...particularly in FDA submissions. This hybrid role is essential for maintaining... 
    Medical device

    Hyperfine

    Palo Alto, CA
    17 hours ago
  • Abbott in the United States is seeking a Senior Project Manager/Clinical Evaluations to support regulatory submissions for medical devices. This on-site role focuses on CER development...  ...collaboration among R&D, Regulatory Affairs, and Quality teams. The CER PM will lead... 
    Senior
    Medical device

    Abbott

    Santa Clara, CA
    2 days ago
  •  ...group is looking for an International Regulatory Affairs Lead to head a team responsible for international...  ...expansion of Apple Health's regulated medical device features. If you are passionate about...  ...Ability to be onsite; this role is a hybrid, in-person position Preferred... 
    Medical device
    Full time

    Apple

    Cupertino, CA
    more than 2 months ago
  • $90k - $180k

     ...Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted...  ...is a global healthcare leader that helps people live...  ...products in diagnostics, medical devices, nutritionals and branded...  ...contributor, the function of a Senior Regulatory Affairs Specialist is to provide... 
    Senior
    Medical device
    Work experience placement
    Worldwide

    Abbott

    Santa Clara, CA
    4 days ago
  • $145k - $167k

     ...MoreAbout The RoleJob Title: Senior Regulatory Affairs SpecialistLocation:Palo Alto, CA or Guilford, CT (Hybrid, 3 days/week)The Senior...  ...strategy for the company’s devices and ensures compliance to Regulatory...  ....Strong knowledge of medical device labeling requirements... 
    Senior
    Medical device
    Work experience placement
    Work at office
    Worldwide
    Work visa
    Night shift
    Weekend work
    3 days per week

    Hyperfine

    Palo Alto, CA
    2 days ago
  • 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,... 
    Senior
    Medical device

    Katalyst Healthcares & Life Sciences

    Santa Clara, CA
    4 days ago
  • $149k - $192k

     ...CeribellCeribell is a medical technology company focused...  ...with key opinion leaders (KOLs) in North America...  ...into product offerings. Regulatory and Compliance...  ...Software as a Medical Device (SaMD). Neurodiagnostics...  ...updates for Ceribell’s senior leadership, ensuring alignment... 
    Senior
    Medical device
    Local area

    Ceribell

    Sunnyvale, CA
    1 day ago
  • $90k - $180k

     ...Full timeAbbott is a global healthcare leader that helps people live more fully at...  ...and products in diagnostics, medical devices, nutritionals and branded generic medicines...  ...devices and peripheral stents.This Senior Regulatory Affairs Specialist position is an on-site... 
    Senior
    Medical device
    Worldwide
    Shift work

    Abbott

    Santa Clara, CA
    1 day ago
  • $92k - $148.35k

     ...their merit.Job Function: Regulatory Affairs GroupJob Sub Function:...  ...the best talent for a Senior Regulatory Affairs...  ...This role will work a Hybrid/Flex schedule with 3 days...  ...such as Quality, Medical, Clinical, R&D.Demonstrated...  ...or Class III Medical Devices strongly preferred.... 
    Senior
    Medical device
    Full time
    Contract work
    Temporary work
    Local area
    Immediate start
    Flexible hours
    3 days per week

    Johnson & Johnson

    Milpitas, CA
    3 days ago
  • A prominent HR solutions firm seeks a Senior Manager, HRIS, to optimize Workday technology and empower staff. In this hybrid role based in Redwood City, CA, you will collaborate across departments to enhance HR technology solutions. Ideal candidates have 4-6 years of Workday... 
    Senior

    Bayside Solutions

    Santa Clara, CA
    2 days ago
  •  ...Description Job Description Senior Software Engineer Payments Java AWS Location: Hybrid (Multiple U.S. Locations)...  ...Maintenance, Construction, Oil and Gas, Medical Communications, Accounting,...  ...Electronics, Scientific, Medical Device, Sales, Pharmaceutical, Admin,... 
    Senior
    Medical device

    Liberty Personnel Services, Inc

    Milpitas, CA
    9 days ago
  •  ...Capital is seeking a Legal Office Administrator in the Palo Alto/San Francisco area with a hybrid schedule. The role leads daily administrative functions, collaborates with senior leadership, and drives strategic initiatives aligning with the firm's goals. The position... 
    Senior
    Work at office

    Ignite Human Capital

    Palo Alto, CA
    1 day ago
  •  ...commercial group to shape portfolio direction and launch plans. The role requires a marketing/product management background in a medical device context, strong cross-functional coordination, and willingness to travel up to 40%. The position is full-time and based in... 
    Senior
    Medical device
    Full time

    Shockwave Medical

    Santa Clara, CA
    17 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Leader - Medical Devices (Hybrid). Be the first to apply!