Senior Regulatory Strategy Leader - Medical Devices
Intuitive Surgical, Inc.
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 toward market authorization. The role emphasizes strategic advisement, regulatory risk assessment, and cross-functional leadership in the US and international markets to accelerate access for innovative robotic systems and #J-18808-Ljbffr Intuitive Surgical, Inc.
- Intuitive Surgical, Inc. in Sunnyvale seeks a Principal Regulatory Affairs Strategist (Finance) to shape upstream regulatory and clinical strategy for emerging surgical technologies. You will collaborate with R&D, Clinical Affairs, Quality, Product, and business teams...SeniorRegulatoryMedical device
- ...at Intuitive. As a global leader in robotic-assisted surgery... ...DescriptionPrimary Function of Position:Senior Strategy Manager, Global Services AI... ....Partner with Quality, Regulatory, Legal, Privacy, and... ...skills.Experience in the medical device, healthcare, life sciences,...SeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group, focusing on regulatory strategy for robotic instruments and accessories. You will collaborate with engineering and clinical teams to develop submissions, drive global...SeniorRegulatoryMedical 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
- ...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 staff. Strong...SeniorRegulatoryMedical device
$109k - $174.8k
...merit. Job Function Regulatory Affairs Group Job Sub... ...the best talent for a Senior Regulatory Affairs Program... ...will lead regulatory strategy development and... ...feedback for specifications, device testing, risk... ...Affairs experience within Medical Device is required (4+...SeniorRegulatoryMedical deviceLocal areaImmediate startRemote work- Intuitive in Sunnyvale seeks an experienced Senior Clinical Study Manager 4 to lead multi-center clinical studies, develop and execute protocols, and manage schedules and budgets to support regulatory approvals and evidence initiatives. The role collaborates with CRAs,...SeniorRegulatory
- ...expanding its Consumer Lending focus and seeks a Senior Credit Risk Analyst to lead data-driven risk strategies across the consumer banking portfolio. You will partner... ...ability to mentor junior analysts while navigating complex regulatory requirements. #J-18808-Ljbffr IntuitSeniorRegulatory
- Intuitive, a global leader in robotic-assisted surgery, seeks a principal-level Regulatory Affairs professional in Sunnyvale to own regulatory strategy across our surgical platform, instruments, disposables, and software. You’ll guide submissions, engage with regulators...SeniorRegulatory
- ...early-stage, pre-commercial medical device company with a vision for Physical... ...Technology is seeking a Senior Systems Engineer with a... ...controls, and verification strategies are effectively translated into robust, traceable, and regulatory-compliant test solutions.In...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
- 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...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... ...Experience determining outsourcing strategies based on capacity, complexity, and criticality...SeniorRegulatoryMedical device
- Apple seeks a Senior Lead Auditor in Cupertino to lead a risk-based internal and supplier audit program ensuring regulatory compliance for medical device features in our Health group. You will conduct audits against ISO 13485, MDSAP, EU MDR and other international standards...SeniorRegulatoryMedical device
- Abbott is seeking an Endovascular, Senior Marketing Manager (US Downstream) to join the... ...for managing US downstream marketing strategy and execution for the Endovascular portfolio... .... The ideal candidate has 8+ years in medical device marketing, strong leadership, and a #J...SeniorMedical device
- ...do at Intuitive. As a global leader in robotic-assisted surgery... ...provides expert support for regulatory project management, strategic... .... • Develop regulatory strategies for new product development... ...timeFunction: Quality AssuranceExperience level: AssociateIndustry: Medical DeviceSeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- 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, review, and regulatory strategy across EU MDR requirements, with cross-functional collaboration...SeniorRegulatoryMedical device
- ...Intuitive. As a global leader in robotic-... ...of the PositionThe Senior Clinical Development... ...environment and medical technology to work... ...productsSupport regulatory documentation and... ...company’s overall strategy and goalsQualificationsRequired... ...in medical device industry with a...SeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- ...Intuitive. As a global leader in robotic-assisted... ...PositionThe Digital Senior Clinical Development... ...assessments, validation strategies, and product... ...human factors, product, regulatory, and quality teams to... ...years of experience in medical device industry with a Bachelor...SeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- ...Intuitive. As a global leader in robotic-assisted... ...to Manger/Sr. Manager, Medical Sciences and requires... ...collaboratively to develop strategies for the creation of... ...product development, regulatory, post-market surveillance... ...areas, competitor devices, current clinical/market...SeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- Morrison Foerster is seeking a Senior Retirement Manager to lead the design, strategy, and administration of the firm’s U.S. retirement plans and POLI program... ...the subject matter expert, oversee a team, ensure regulatory compliance, and partner with HR, Finance, Legal, and...SeniorRegulatory
- Johnson & 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 vision subsystems across development and lifecycle management, with a strong focus...SeniorRegulatory
- ...Intuitive. As a global leader in robotic-... ...Function of Position: Senior Quality Engineer... ...control and regulatory requirements. Essential... ...Contribute to the strategy and execution of risk... ...• Experience with medical standards... ...ManufacturingExperience level: AssociateIndustry: Medical DeviceSeniorRegulatoryMedical deviceWork experience placementLocal areaWorldwideFlexible hours
$149.2k - $249k
...it. Description The Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate about the health space... ...& supplier audit program to ensure ongoing regulatory compliance and encourage continuous improvement. Responsibilities...SeniorRegulatoryMedical deviceRelocation$90k - $180k
...Type: Full timeCategory: Regulatory AffairsIndustry:... ...is a global healthcare leader that helps people live... ...products in diagnostics, medical devices, nutritionals and... ...contributor, the function of a Senior Regulatory Affairs... ...regional regulatory strategy and update strategy based...SeniorRegulatoryMedical deviceWork experience placementWorldwide$90k - $180k
...a global healthcare leader that helps people live... ...products in diagnostics, medical devices, nutritionals and... ...countries.About the RoleThis Senior Site Reliability... ...and implement strategies for scaling our services... ...security, marketing, and regulatory teams.Strong...SeniorRegulatoryMedical deviceRemote work- ...Intuitive. As a global leader in robotic-assisted... ...clinical affairs, legal, regulatory, and Market Access /... ...integrated marketing strategies that accelerate da... ...impactful presentations to senior and executive... ...experience in a therapeutic medical device company preferred....SeniorRegulatoryMedical deviceFull timeLocal areaWorldwideFlexible hours
- ...Intuitive. As a global leader in robotic-... ...exceptional Counsel/Senior Counsel, Intellectual... ...scientists, and medical experts to advance... ...IP-related deal strategies.The Counsel/Senior... ...about industry and regulatory developments as well... ...to medical devices, robotics, mechanical...SeniorRegulatoryMedical deviceWork at officeLocal areaImmediate startWorldwideFlexible hours
- ...Intuitive. As a global leader in robotic-assisted... ...instruments platforms. This Senior Mechanical Design... ...within your area; support regulatory and standards... ...patent development and IP strategy.Observe clinical cases... ...engineering experience (medical device industry preferred).Expertise...SeniorRegulatoryMedical deviceLocal areaWorldwideFlexible hours
- ...Intuitive. As a global leader in robotic-assisted... ...Function of Position:The Senior Manager, Technical... ...is responsible for the strategy, delivery, optimization... ...initiatives across a global medical device organization.This is a... ...with applicable regulatory requirements, including...SeniorRegulatoryMedical deviceContract workLocal areaWorldwideFlexible hours
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