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
- Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for the Vascular... ...Santa Clara, CA or Temecula, CA. You will lead regulatory strategy, manage global submissions... ...in medical devices, experience with Class II/III devices, and strong collaboration across...SeniorRegulatory
- ...organization seeks an experienced Program Manager to steer cross-functional development programs across hardware, software, clinical and regulatory teams. You will drive requirements analysis, architectural design, software development, QA, deployment, and market rollout while...SeniorRegulatory
- 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...SeniorRegulatory
- 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...SeniorRegulatoryWorldwide
- 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...SeniorRegulatory
- 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 6‑month contract role requires deep regulatory expertise and strong cross‑functional...SeniorRegulatoryContract work
- Icehouseventures is seeking a Senior Public Policy Lead to spearhead the U.S. public policy program in California. You will lead engagements with... ...years of experience in public policy and knowledge of the regulatory landscape, along with strong communication skills. This is...SeniorRegulatoryFull time
- Intuit is expanding its Consumer Lending focus and seeks a Senior Credit Risk Analyst to lead data-driven risk strategies across the consumer banking... ...skills, and the ability to mentor junior analysts while navigating complex regulatory requirements. #J-18808-Ljbffr IntuitSeniorRegulatory
$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- Logos Space is looking for a Senior Business Development Lead based in Mountain View or San Diego. This role involves building and closing sales... ...communication sector, engaging with key enterprises and regulatory bodies. The ideal candidate will have a strong background...SeniorRegulatory
- Apple Inc. in Cupertino, California is seeking a Principal Regulatory Affairs Associate for their health products team. This role involves leading regulatory initiatives to obtain approvals for innovative medical devices, requiring 10+ years of medical device regulatory...Regulatory
- .... Environmental Engineer (Satellites) to join the EHS team and lead environmental compliance for satellite and dish manufacturing across... ...You will develop programs, perform audits, manage permits and regulatory reporting, and collaborate with engineering teams in a fast-...SeniorRegulatory
- ...The Health group is looking for an International Regulatory Affairs Lead to head a team responsible for international expansion of Apple... ...assessments of regulatory impact for new and modified wellness, Class I, II and III products, including identification of assumptions/risks/...RegulatoryFull time
- ...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
- The City of Cupertino's Community Development Department seeks a Senior Building Inspector with strong customer service and leadership... ...inspections, and training junior inspectors while upholding safety and regulatory standards. #J-18808-Ljbffr City of Cupertino, CASeniorRegulatory
$142k - $244.95k
...in Innovative Medicine and MedTech, we are uniquely... ...engineering, quality, PMO, and regulatory to translate global cybersecurity... ...mitigation strategies. - Lead emerging cyber... ...validation. - Expertise in Class I, Class II, and Class III medical devices, including...SeniorRegulatoryFull timeWork experience placementLocal areaImmediate startShift work- 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
- Johnson & Johnson is seeking a Senior Quality Compliance Engineer- Shockwave Medical to join our Santa Clara, CA team. The role focuses... ...environmental monitoring and calibration programs meet regulatory standards. The candidate will coordinate audits, collaborate with...SeniorRegulatory
- ...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
- Why Join Sunrise Senior LivingAt Sunrise Senior Living, we believe meaningful work starts... ...the quality of life for all seniors. As a Lead Dining Server, you support daily dining... ...Follow all food safety, sanitation, and regulatory guidelines • Support special events and Bistro...SeniorRegulatory
$265k - $331.3k
...pillar of our Autonomy stack. In this Tech Lead role, you will drive and deliver the... ...employment, 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$26 - $40 per hour
...three decades, Cirtec Medical has been a leading outsourcing partner for complex medical... ...providing comprehensive solutions for Class II and III devices, from design and development to... ...in leading team performance and regulatory compliance. Be able to read, write and...RegulatoryContract workTemporary workAll shiftsMonday to FridayShift 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$92k - $148.35k
...Innovative Medicine and MedTech, we are uniquely... ...merit.Job Function: Regulatory Affairs GroupJob Sub... ...the best talent for a Senior Regulatory Affairs Specialist... ...lifecycle stages.Leads preparation and... ...Prior experience with Class II or Class III Medical Devices strongly...SeniorRegulatoryFull timeContract workTemporary workLocal areaImmediate startFlexible hours3 days per week$265k - $331k
...The Perception Adaptation and Integration Lead will oversee the deployment of our core... ...employment, 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 areaImmediate startShift work$120 - $175 per hour
...- No 3rd party candidates Location: Bay Area-based role Work Model: 5 days onsite per week We are seeking a Senior Regulatory Submission Lead to support a critical BLA submission across Module 2 and Module 5. This 1 year contract role will provide hands-on submission...SeniorRegulatoryHourly payContract work- ...a subsidiary of Fosun International, a leading Pharma and Medical Device Company in China... ...engineering, design, human factors, and regulatory affairsFacilitate and ensure that... ...to manufacturingExperience in designing class III software products within FDA-regulated or...SeniorRegulatoryLocal areaWorldwideFlexible hours
- ...developing Dragonfly, a portable microwave-based brain scanner for rapid stroke detection at the point of care. We're looking for a Senior Regulatory Affairs Specialist to own our global regulatory strategy and drive Dragonfly through FDA clearance and international market...SeniorRegulatory
- Morrison Foerster is seeking a Senior Retirement Manager to lead the design, strategy, and administration of the firm’s U.S. retirement plans and... ...serve as the subject matter expert, oversee a team, ensure regulatory compliance, and partner with HR, Finance, Legal, and...SeniorRegulatory
- EY is seeking an OT Senior Architecture & Governance professional to lead governance, defect management, and architectural oversight across OT environments.... ...stakeholders while aligning with enterprise architecture standards and regulatory requirements. #J-18808-Ljbffr EYSeniorRegulatory
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