Senior Regulatory Lead: Class III MedTech & SaMD
Real
A 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 staff. Strong background in regulatory affairs and experience with software-embedded products are essential. The position offers a hybrid work culture, allowing flexibility while contributing to transformative cardiac care. #J-18808-Ljbffr Real
- ...expertise in Innovative Medicine and MedTech, we are uniquely positioned to... ...recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory... ...for the best talent for a Senior Regulatory Affairs Program Lead to support our OTTAVA robotics group...SeniorRegulatoryRemote workFlexible hours
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy for OTTAVA robotics. You will collaborate with engineering and clinical teams to advance robotic instruments and accessories through global submissions and approvals. The...SeniorRegulatoryRemote job
- MedDev Solutions is seeking a hands-on Senior Business Development Manager to expand our presence across the San Francisco Bay Area and... ...leadership and cross-functional experts in software, quality, regulatory, cybersecurity, AI, and verification & validation to deliver...SeniorRegulatoryContract work
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support OTTAVA robotics. The role leads regulatory strategy for NPD/LCM, collaborating... ..., maintain compliance with FDA requirements, and contribute to the global #J-18808-Ljbffr Johnson & Johnson MedTechSeniorRegulatoryRemote job
- Johnson & Johnson in the MedTech Quality organization seeks a Senior Manager, Quality Management Systems to lead the strategy, governance, and digital transformation of the... ...Cincinnati, OH. You will partner with quality, regulatory, R&D, supply chain and clinical teams to...SeniorRegulatory
- Intuitive seeks a Lead Biostatistician to define the statistical vision for clinical studies from early feasibility to post-market... ...design decisions, set standards, and represent statistics with regulatory bodies and external partners. You will mentor staff, develop SOPs...SeniorRegulatory
- Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group in Santa Clara, CA. This role leads regulatory strategy across development, submissions, and lifecycle management for electromechanical, software-enabled devices....SeniorRegulatoryRemote job
- ...Lawyer / Attorney / Counsel - Junior / Senior / Lead Sunnyvale, California, United States About the Job Catalyst Labs is a leading talent agency with a specialized vertical in Legal, Regulatory Compliance, and Corporate Governance. We operate deeply inside our...SeniorRegulatoryContract work
$149k - $192k
...driven features into product offerings. Regulatory and Compliance Leadership: Ensure... ...and Software as a Medical Device (SaMD). Neurodiagnostics Expertise: Lead the development of products... ...and release updates for Ceribell’s senior leadership, ensuring alignment across...SeniorRegulatoryLocal area- ...CreditKarma, and Canada, translating business requirements into actionable strategies and ensuring alignment with delivery models and regulatory constraints. The role emphasizes customer-focused thinking, data-driven insights from VOC and performance metrics, and story-...SeniorRegulatory
- Abbott is seeking a Senior Medical Writer / Senior Project Manager, Clinical Evaluation to... .... The role combines clinical evaluation, regulatory expertise, and project leadership to... ...from literature and investigations, and lead regulatory responses with internal teams...SeniorRegulatory
- Apple Inc. seeks an experienced Senior Wireless Systems Validation Engineer to own end-to-end validation for next... ...across Sunnyvale, San Diego, and Irvine. You will lead lab bring‑up, RF/baseband testing, and regulatory workflows, driving robust automation and cross‑functional...SeniorRegulatory
$265k - $331.3k
...The Perception Onboard Robotics Software Lead will direct the development of our deterministic... ..., background and reference checks; (iii) establishing an employment relationship... ...with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v)...SeniorRegulatoryFull timeContract workTemporary workPart timeLocal areaShift work$140.4k - $175.5k
...rapidly scaling global organization. You'll lead process mapping and redesign across our... ..., background and reference checks; (iii) establishing an employment relationship... ...with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v)...SeniorRegulatoryHourly payFull timeContract workTemporary workPart timeLocal areaImmediate startShift workDay shift- NeuroPace, based in Mountain View, CA, seeks a Senior Regulatory Affairs Manager to lead regulatory support for new product development, sustaining, and clinical study projects for a fully implantable US Class III medical device system. This hybrid role requires involvement...SeniorRegulatoryWork at office
- Overview Join a pioneering MedTech company that's... ...client seeks a Principal Regulatory Affairs Specialist to lead complex regulatory strategies and submissions for Class III implantable devices and software... ...including software-embedded and SaMD products. Mentor and train...Regulatory
- ...with R&D, AI, and data science teams, translate clinician input into concrete requirements, and guide cross-functional teams across regulatory and clinical landscapes to deliver groundbreaking EEG-focused solutions. #J-18808-Ljbffr Ceribell │ AI-Powered Point-of-Care EEGSeniorRegulatory
- Samsung Research America is seeking an experienced product management leader to drive the next generation of SaMD within Samsung Health. You will define vision, requirements, and roadmaps, guiding cross-functional teams across design, engineering, analytics, and QA to...Senior
- Samsung Research America seeks an experienced product management leader to drive the next generation of SaMD within the Digital Health team. You will define product vision, requirements, and strategy, influencing stakeholders to deliver high-value Health solutions. The...Senior
- Samsung Research America is seeking an experienced product management leader to build the next generation of SaMD within the Digital Health team. You will articulate the product vision, define requirements, and drive cross-functional delivery across design, engineering...Senior
$173k - $216.3k
...Business Development team, you will lead the structuring and execution... ...execution. You will work with senior leaders, internal cross-... ...background and reference checks; (iii) establishing an employment... ...iv) complying with our legal, regulatory and corporate governance obligations...SeniorRegulatoryFull timeContract workTemporary workPart timeLocal areaShift work- Cirtec Medical Corporation seeks a Quality Manager to lead Quality personnel and resources, ensuring QMS compliance... .... This role oversees QA, QC, CAPA, audits, and regulatory compliance across Class II and III medical devices. We require a STEM bachelor’s, 7+ years...SeniorRegulatoryContract work
$90k - $180k
...spectrum of healthcare, with leading businesses and products in diagnostics... ..., the function of a Senior Regulatory Affairs Specialist (International... ...history/background of class, disease/ therapeutic/diagnostic... ...working with Class II and/or Class III medical devices. Regulatory...SeniorRegulatoryWorldwideShift work- Intuitive Surgical is seeking a Senior Program Manager to lead digital infrastructure initiatives across cloud platforms and platform engineering... ...business units and cross-functional teams. The role emphasizes regulatory compliance, risk management, and process improvements in...SeniorRegulatory
$130.7k - $261.3k
...spectrum of healthcare, with leading businesses and products in diagnostics... ...We are recruiting for a Senior Regulatory Affairs Manager to join our... ...as a Medical Device (SaMD).Regulatory Compliance & Product... ...Regulatory Requirements for class II medical devices and EU Medical...SeniorRegulatoryWork experience placementWorldwideShift work- ...PayPal is seeking a Senior Lead Product Manager in San Jose, CA to plan and implement an architectural roadmap balancing innovative design, regulatory requirements, and profitability. You will design and drive product strategy with cross-functional stakeholders and lead...SeniorRegulatory
- Abbott is seeking an Endovascular, Senior Marketing Manager (US Downstream) to join the Strategic... ...for the Endovascular portfolio and leads campaigns, launches, and market insights... ...Sales, Clinical, Medical Affairs, and Regulatory to drive commercial excellence and ensure...SeniorRegulatory
- ...is seeking an AML and Sanctions - Fenergo Principal Product Consultant - Senior Manager to leverage data and analytics for strategic client insights in the Risk & Regulatory practice. You will lead cross-functional teams, design Fenergo configurations, and deliver...SeniorRegulatory
- Johnson & Johnson seeks a Senior Manager, Quality Management Systems to lead QMS strategy, governance, and global compliance across Auris sites. This role... ...partners with Quality, Compliance, R&D, Supply Chain, Regulatory Affairs and Clinical to ensure scalable, compliant...SeniorRegulatory
- Intuitive Surgical, Inc. is seeking a Clinical Study Manager-4 to lead and execute clinical and outcomes research studies that support regulatory approvals and strategic evidence initiatives. You will collaborate with CRAs, CTAs, data managers, and biostatisticians to design...SeniorRegulatoryRemote job
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