Senior Regulatory Affairs Lead - Class III PMA Submissions
Shifamed
Shifamed is seeking a Principal Regulatory Affairs Specialist in Los Gatos, CA to lead US, EU, and Japan regulatory activities for a class III mechanical circulatory support device. The role focuses on submission strategy, planning, and writing with Supira Medical team and consultants. Responsibilities include writing major submissions (IDE, PMA, EU Design Dossiers, Shonin), coordinating priorities, guiding team, and ensuring regulatory compliance; hybrid work, competitive salary, equity. #J-18808-Ljbffr Shifamed
- ...pioneering MedTech company in California is looking for a Principal Regulatory Affairs Specialist to spearhead complex regulatory strategies for Class III devices. This role involves authoring PMA submissions, ensuring compliance for medical devices, and mentoring junior...Senior
- Imperative Care, based in Campbell, California, seeks a Lead Regulatory Affairs Specialist for on-site, full-time employment. You will lead... ...compliance, and managing filings such as 510(k) and Notified Body submissions. The role requires a strong background in US/OUS...SeniorFull time
- Abbott seeks a Principal Regulatory Affairs Specialist to provide regulatory leadership for endovascular medical devices in Santa Clara,... ...other markets, supporting lifecycle management and global submissions. The role requires experience with FDA submissions, EU MDR,...Senior
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group, focusing on regulatory strategy for robotic... ...with engineering and clinical teams to develop submissions, drive global regulatory milestones, and ensure alignment...Senior
- 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...SeniorWorldwide
- System One is seeking a Sr. Regulatory Affairs Specialist in Sunnyvale, CA. The role requires a BS degree and at least... ...Affairs experience in medical devices. You will lead regulatory plans, prepare FDA 510(k) submissions, and guide product teams on US, Canada, and EU pathways...Senior
$150k - $180k
Position: Principal Regulatory Affairs Specialist Location: Los Gatos, CA... ...Regulatory Affairs activities for a class III, Breakthrough mechanical... ...support system filed under PMA, EU Design Dossier(s) and... ...significant portion of time to submission strategy, planning and...Full timeTemporary workWork experience placementWork at office$109k - $174.8k
...recognize their merit. Job Function Regulatory Affairs Group Job Sub Function... ...searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Instrumentation &... ...product development stages, generating submission ready documentation, and...SeniorLocal areaImmediate startRemote work- Senior Regulatory Affairs Specialist Tiposi Tiposi is developing Dragonfly, a portable... ...FDA (510(k), De Novo, PMA, BDD/Q-Sub) and EU MDR pathways Lead preparation and submission of regulatory filings,... ...frameworks Experience with Class II-III devices; combination products...Senior
- ...Sunnyvale seeks a principal‑level Regulatory Affairs professional to lead regulatory strategy across robotic... ...disposables, and software. You will shape submission and lifecycle strategies from... ...premarket submissions (510(k), De Novo, PMA), interact with agencies, and...Worldwide
- ...innovative solutions. The client seeks a Principal Regulatory Affairs Specialist to lead complex regulatory strategies and submissions for Class III implantable devices and software-driven... ...Author and manage Original PMA submissions and PMA supplements. Drive regulatory...
$148.55k - $174.77k
...are treated? Join us as a Senior Regulatory Affairs Specialist and be at the forefront... ...for new and modified Class II and III devices and preparing and submitting regulatory submissions in the US, EU and outside of... ...-Day Will InvolveAct as a lead regulatory representative on...SeniorFull time$100k - $200k
...Full timeCategory: Regulatory AffairsIndustry:... ..., with leading businesses and products... ...Regulatory Affairs Specialist to join... ...assessments, and global submissions. This individual... ...510(k)s, PMAs, PMA supplements, and... ...working with Class II and/or Class III devices....For contractors- ...Johnson is seeking an Associate Director, Regulatory Affairs for our Robotics & Digital Solutions unit in Santa Clara, CA. This role leads regulatory strategy for software and... ...management, with a strong focus on US FDA submissions and global registrations. You will manage...Senior
- Kelly Services seeks a Sr Regulatory Affairs Specialist to lead regulatory reporting assessments for manufacturing, facility, product, and packaging changes on a global scale. You will advise project teams on regulatory impacts, liaise with regulators during audits, and...SeniorRemote jobContract work
$160k - $190k
...We are currently seeking a Senior Regulatory Affairs Manager to join our team. This... ...study projects and related submissions for a highly technical and... ...active implantable US Class III medical device system. Key... ...levels of complexity (including PMA 180-Day Supplements, Real...SeniorWork at office2 days per week3 days per week- ...international studies. You will lead start-up activities, monitor... ...and ensure data quality and regulatory readiness across complex... ...the Sr. Director of Clinical Affairs, you will manage timelines, budgets... ...to drive successful submissions and #J-18808-Ljbffr Akura MedicalSenior
- ...Attorney / Counsel - Junior / Senior / LeadSunnyvale, California, United... ...the JobCatalyst Labs is a leading talent agency with a specialized vertical in Legal, Regulatory Compliance, and Corporate... ...of impactful cases, regulatory submissions, process improvements, policy...SeniorContract work
$90k - $180k
...of healthcare, with leading businesses and products... ...stents.This Senior Regulatory Affairs Specialist position is... ...history/background of class, disease/ therapeutic... ...Determine and communicate submission and approval requirements... ...with US (510(k). PMA) and EU (Technical Documentation...SeniorWorldwideShift work- Apple Inc. is seeking a Principal Regulatory Affairs Associate in Cupertino, CA, to lead regulatory strategy for medical devices and SaMD products. This hybrid, in-person role will drive submissions and regulatory plans for US and global markets. The successful candidate...
$130.7k - $261.3k
...of healthcare, with leading businesses and products... ...are recruiting for a Senior Regulatory Affairs Manager to join our... ...compiling regulatory submissions and ensure data is effectively... ...design changes for PMA approved products, 51... ...Requirements for class II medical devices...SeniorWork experience placementWorldwideShift work$150k - $180k
...Description: The Senior Manager, Clinical... ...audit-ready and submission-ready, and works... ...Medical Safety, and Regulatory Affairs to keep the trial... ...& Governance: Lead CRF development and... ...supplements and PMA submission. Team... ...heart, or other Class III device, from CRF...SeniorFull timeTemporary workWork experience placementInterim role$115.5k - $156.4k
...belong. The Opportunity: The Senior Regulatory Affairs Specialist represents the Regulatory... ...high quality technical documentation/submissions for regulatory approval in the US and... ...Regulatory Affairs experience within the Class III medical device industry. Strong...SeniorLocal areaFlexible hoursNight shift$151k - $178k
Title: Lead Regulatory Affairs Specialist This position is based in our Campbell, California offices. This position is on-site, full-time.Why... ...filings such as but not limited to Letters-To-File, Pre-Submissions, Investigational Device Exemptions, 510(k)s, Technical Documentation...Full timeWork experience placementShift work$111.2k - $258.7k
...Endocrinology and Fertility Subchapter lead in the Medical Value Assays... ...of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT).... ...’ efforts with best-in-class expertise You act as... ...have experience with global submissions for US FDA (Class 1-3), EU Notified...Local areaRelocation package- Arycs Technologies in Los Gatos, CA, seeks a Staff ASIC Implementation Engineer to lead RTL-to-synthesis, timing analysis, and tapeout readiness for DSP ASIC programs. You will coordinate with RTL/verification and external backend teams to drive PPA optimization and design...Senior
- Google in Sunnyvale, CA is hiring a Functional Compliance IC to establish standards and translate regulatory obligations into scalable frameworks across gUP. You will own key compliance workstreams and partner with cross-functional teams to align business goals with regulatory...Senior
- Apple Inc. in Cupertino, California, is seeking a Senior EPM for Foundation Models to own the end-to-end program for world-class AI initiatives. You will define the master plan, set goals with DRIs, and translate extreme technical complexity into clear executive communications...Senior
- El Camino Health Medical Network seeks a Senior Financial Data Analyst to lead dashboards, FP&A, and reporting for a growing healthcare finance team. You will design models, build forecasts, and deliver planning frameworks guiding organizational decisions. The ideal candidate...Senior
- Intuitive Surgical is seeking a Principal Regulatory Affairs Strategist to shape early regulatory and clinical strategy for emerging surgical technologies. You will collaborate with R&D, Clinical, Quality, and Product teams to define use, indications, claims, and pathways...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead - Class III PMA Submissions. Be the first to apply!
- senior network engineer remote Los Gatos, CA
- senior manager legal Los Gatos, CA
- senior manager tax Los Gatos, CA
- senior living Los Gatos, CA
- senior implementation project manager Los Gatos, CA
- senior level Los Gatos, CA
- senior resident engineer Los Gatos, CA
- senior cloud network engineer Los Gatos, CA
- senior activities Los Gatos, CA
- international tax senior Los Gatos, CA

