Regulatory Strategy Director - Neurotech (Class III, PMA)
Epia Neuro
Epia Neuro in Alameda, CA is seeking a Director of Regulatory Affairs to lead and execute regulatory strategy for Class III implantable neurotechnology. You will report to the CEO and own the end-to-end regulatory pathway from early FDA engagement through IDEs and PMA submission. This role requires deep FDA knowledge, ISO standards, and a track record with Q-Subs, Breakthrough Device Designation, and IDEs. You will lead cross-functional teams and shape the regulatory direction while staying #J-18808-Ljbffr Epia Neuro
$195k - $277.5k
...Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health... ...veteran, and basis of disability or any other federal, state or local protected class.SummaryLocation: Alameda, CAType: Full timeSuggestedFull timeWork at officeLocal areaFlexible hours- ...Emeryville, California and privately-held with world class investors and partners. Role Summary This role... ...detection tools to market globally by leading regulatory strategy across the full product lifecycle. The Director owns the overall regulatory strategy for the company...SuggestedWork at office
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...new sensing technology. This Regulatory Affairs Manager position is... ...talent, shape regulatory strategy, and partner across functions... ...pre-submissions, 510(k), PMA, and post-market activities... ...submissions.Experience with Class II and Class III medical devices.Ability to...SuggestedShift work- Exelixis Inc in Alameda, CA is seeking a Regulatory Affairs leader to develop and implement global regulatory strategies that align with asset and corporate goals and health authority requirements. You will ensure timely preparation of organized, scientifically valid submissions...
- ...population. The Role We’re looking for a Director of Regulatory Affairs for our office in Alameda,... ...and execute the regulatory strategy for Epia Neuro’s Class III implantable neurotechnology. As a... ...early FDA engagement through IDEs and PMA submission and approval, and...Full timeWork at office3 days per week
$268.5k - $380k
...SUMMARY/JOB PURPOSE:The Executive Director, Regulatory Affairs has oversight for all regulatory... ...developing and implementing global regulatory strategies encompassing clinical, non-clinical... ...federal, state or local protected class.SummaryLocation: Alameda, CAType: Full...Full timeContract workWork at officeLocal areaFlexible hours- Ray Therapeutics, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategy for clinical programs. Reporting to the Chief Regulatory Officer, you will oversee INDs and early-to-mid stage development, prep for NDA/BLA discussions, and guide cross...
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...cross-functional teams to build sourcing strategies and drive towards commercial success for... ...Sourcing Manager will report to the Director of Hardware and Manufacturing Strategic... ...forecasts.Work hands-on and support a world-class team of engineers and business leadersWe...Hourly payContract workWork at officeLocal areaRemote workFlexible hours$105k - $150k
...leading provider of standard, configurable, and custom manufacturing solutions. By integrating a vast catalog of components with a world-class digital manufacturing platform, MISUMI Americas empowers engineers and procurement teams to accelerate innovation across the entire...Remote work$148.7k - $297.3k
...scientists.The Opportunity This Associate Director Regulatory Affairs will work on-site out of our... ...to shape and execute regulatory strategies across the total product life cycle, driving... ...Society.)Experience with Class III US and EU submissions and Software as...WorldwideShift work$261k
...continues to scale, we are looking for a Senior Manager, Brand Strategy to ensure our brand strategy is clear, durable, and actionable... ...reducing rework and late-stage misalignmentLead and develop a best-in-class team of passionate, data-driven Brand Strategists (4...$268.5k - $380.5k
...biologics research and development strategies aligned with corporate... ...Biotherapeutics team, the Executive Director of Biologics Innovation &... ...translational medicine, CMC, regulatory, and clinical development.... ...federal, state or local protected class.SummaryLocation: Alameda,...Full timeWork at officeLocal areaFlexible hours- The University of California - San Francisco is seeking a leader in Health Information Management to oversee all outpatient coding operations. The role requires extensive experience in coding and healthcare operations, with an emphasis on compliance and quality assurance...
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SUMMARY/JOB PURPOSE: The Associate Regulatory Operations Director is responsible for overseeing submission... ..., risks, or impact due to changes in strategy and/or timelines are assessed quickly... ...federal, state, or local protected class.#LI-MB1Our compensation reflects the...Full timeWork at officeLocal areaFlexible hours- ...Blue Shield of CA is seeking a Strategic Planning and Performance Principal to support the P&E Strategy, Analytics and Talent Acquisition mandate. You will help create and execute annual plans across operational, financial, human capital and tech domains, and report on...
$248k - $352.5k
...Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health... ...disability or any other federal, state, or local protected class.Notice to Recruiters/Staffing AgenciesRecruiters and...Full timeContract workWork at officeLocal areaFlexible hours$75k - $100k
...leading provider of standard, configurable, and custom manufacturing solutions. By integrating a vast catalog of components with a world-class digital manufacturing platform, MISUMI Americas empowers engineers and procurement teams to accelerate innovation across the entire...$206k - $316k
The Basics:We are looking for a Director, R&D and Strategic Finance, to act as a key finance partner... ...to R&D leadership (Engineering, Product, and Strategy), owning budget management for these orgs while providing best-in-class financial modeling, analyses, and insights to...Full timeLive inWork at officeWorldwideFlexible hours3 days per week- Kyverna is seeking a senior program leader to drive the enterprise compliance buildout and commercialization-readiness initiatives. This role coordinates cross-functional workstreams, owners, milestones, dependencies, and risk escalation while aligning with corporate objectives...
$164.5k - $234.5k
...implementation of the recruitment and retention strategy while ensuring adherence to global... ...clinical trials. Knowledge of GCP and regulatory requirements related to conducting... ...other federal, state or local protected class. In addition to the base salary, as part...Work at officeLocal areaWorldwideFlexible hours$140k - $160k
Join to apply for the Program Manager III role at Ampex Data Systems Join to apply for the Program Manager III role at Ampex Data Systems Program Manager III Do you excel in an environment that values working and playing hard? Would you like to be part of a team developing...Full timeContract workTemporary workRemote workVisa sponsorship$268.5k - $380.5k
...religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. COMPENSATION AND BENEFITS The base pay range for this position is $268,500 - $380,500 annually. The base pay may vary based on...Local areaFlexible hours$157.5k - $222.5k
Overview The Associate Regulatory Operations Director is responsible for overseeing submission activity for... ..., risks or impacts due to changes in strategy and/or timelines quickly throughout... ...any other federal, state, or local protected class. #J-18808-Ljbffr Exelixis IncLocal areaFlexible hours- Eko is seeking a Director of Regulatory Affairs to lead global strategy for SaMD and hardware. You will own FDA/CE/Health Canada submissions, shape regulatory pathways, and partner with R&D, Quality, and Commercial teams to accelerate compliant market access. You will...
$246k - $349.5k
...purpose of the job):The Senior Director, Clinical Operations... ...risk-based decisions.Define strategy and methodology for functional... ...external scientific, legal and regulatory environment.Prior experience... ...federal, state or local protected class.SummaryLocation: Alameda, CAType...Full timeWork at officeLocal areaRelocationFlexible hours$165k - $253k
Tanium is seeking a Sales Operations Director for Revenue Intelligence in Emeryville, CA. The ideal candidate will drive strategy, scalability, and efficiency in the Global Sales Organization while maintaining strategic alignment with sales and operations leadership. This...Full time- ...Sourcing role is responsible for developing and executing sourcing strategies that align with the goals of the Vegetation Management... ...Vegetation Management Strategic Sourcing will report to the Senior Director, Construction Services Strategic Sourcing.Job Responsibilities...Contract workTemporary work
$130.7k - $261.3k
...people monitor their glucose levels with our new sensing technology. As the Manager, Strategic Planning you will support the Head of Strategy and Business Development in driving divisional strategic planning. The Strategic Planning team assists senior leadership in making...Work experience placementWorldwide
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