Principal Regulatory Affairs Lead — Medical Devices
Apple Inc.
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 will have extensive FDA experience and a strong engineering background, with oversight responsibilities in a fast-paced Health group. You will work across cross-functional teams to ensure regulatory compliance, manage complex #J-18808-Ljbffr Apple Inc.
- ...innovative solutions. The client seeks a Principal Regulatory Affairs Specialist to lead complex regulatory strategies and... ...for Class III implantable devices and software-driven technologies.... .... Ensure compliance for Class III medical devices, including software-embedded...PrincipalMedical 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...Medical device
- ...of Position This is a principal-level individual contributor... ...role responsible for regulatory strategy across a... ...Advisory Leadership • Lead regulatory strategy across... ...of related regulatory affairs experience with a... ...strategy for complex medical device systems, including surgical...PrincipalMedical deviceLocal areaWorldwideFlexible hours
- ...The Health group is looking for a Principal Regulatory Affairs Associate to help drive strategy and... ...a rigorous regulatory structure for medical devices. Description You will represent... ...5+ years as a principal, manager or lead. Significant experience in leading...PrincipalMedical deviceFull time
- 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...Medical 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...Medical deviceWorldwide
$100k - $200k
...ClaraJob Type: Full timeCategory: Regulatory AffairsIndustry:... ...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...motivated and experienced Principal Regulatory Affairs Specialist to join our...PrincipalMedical deviceFor contractors$111.2k - $258.7k
...unassailable ethics, and access to medical innovations for all. We do... ...Chemistry II Subchapter lead in the Medical Value Assays... ...of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT).... ...Pharmaceutical, and /or Medical Device industry; Regulatory...Medical deviceFull timeLocal areaRelocation package$109k - $174.8k
...their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory... ...Regulatory Affairs Program Lead to support our... ...feedback for specifications, device testing, risk management, and... ...Regulatory Affairs experience within Medical Device is required (4+ years...Medical deviceLocal areaImmediate startRemote work- ...growth opportunities.The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership for product... ...Regulatory Affairs.The ideal candidate would have had previous medical device experience and looking for potential for growth.What...PrincipalMedical deviceFull timeWork at office
- ...Engineer to oversee end-to-end quality investigations across manufacturing, supplier, and design activities. You will lead CAPA, risk assessment, and regulatory readiness, mentoring junior engineers and ensuring GMP/ISO/FDA compliance across the Endoluminal product family....Medical 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...Medical 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...Medical device
$148.7k - $297.3k
...all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries...PrincipalMedical device$114k - $228k
...technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our... ...process for Product Development, Quality, Ops, Regulatory organizations to support program costingOwn the...PrincipalMedical device$149.2k - $249k
...together, committing to the values that lead to great work. Every new product we... ...Senior Lead Auditor to support regulated medical device features. If you are passionate about the... ...audit program to ensure ongoing regulatory compliance and encourage continuous improvement...Medical deviceRelocation$165.8k - $308k
...bioinformatics pipeline verification.Proficiency in AWS and Linux Shell environmentsSoftware verification experience focusing on medical device software or regulated applications.Relocation benefits are not available for this postingThe expected salary range for this...PrincipalMedical deviceFull timeLocal areaRelocation package$148.7k - $297.3k
...spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...:Abbott Vascular is seeking a Principal AI/ML Engineer to develop... ...validation, risk management, and regulatory submissions.Required QualificationsMaster...PrincipalMedical device- ...teams, ideally suited for a Principal or Senior Principal Mechanical... ..., organize, and lead multi-disciplinary R&D initiatives... ...analyses, and contribute to regulatory/standards compliance.Collaboration... ...engineering experience (medical device industry preferred).Deep expertise...PrincipalMedical deviceLocal areaWorldwideFlexible hours
- ...DescriptionPrimary Function of Position The Principal Modeling Engineer will play a... .... Specifically, this role will lead the thermal management of the 3D... ...Skills & Experience Experience with medical device design and applicable regulatory requirements.Solidworks, Matlab,...PrincipalMedical deviceWork experience placementLocal areaWorldwideFlexible hours
- ...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...Medical device
$140k - $170k
...solutions. We design novel access device technology for vascular... ...attitude. Position Title: Principal, FP&A Job Location: 4245 Technology... ...with the CFO, this role will lead planning, forecasting, and... ...~ Experience in the Medical Devices industry preferred but...PrincipalMedical deviceFull time$232k - $368k
...is possible.NVIDIA’s Silicon Co-Design Group is hiring a Chip Lead to serve as the technical lead for one of our most consequential... ...the crowd:Prior experience as a Chip Lead, Project Tech Lead, or Principal or Distinguished Engineer on a flagship GPU, AI accelerator,...PrincipalFull time- ...of the human hand. The Principal Engineer will strive... ...safest and highest quality devices for minimally invasive... ...performance, and cost.Lead studies to... ...requests for approval by regulatory agencies such as the FDA... ...regulatory requirements for medical devices (FDA, ISO 1348...PrincipalMedical deviceLocal areaWorldwideFlexible hours
- LTIMindtree in Santa Clara, CA, seeks a ServiceNow Principal Engagement Manager to lead large, cross-functional engagements across customers and partners. You will drive governance, risk, resourcing and outcomes while ensuring alignment with client goals. You will mentor...Principal
- ...range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.SummaryType: Full-timeFunction: General BusinessExperience level: AssociateIndustry: Medical DevicePrincipalMedical deviceWork at officeLocal areaWorldwideFlexible hours
- A leading health technology firm is seeking a Regulatory Affairs Specialist to manage regulatory submissions and compliance activities for innovative medical devices. The ideal candidate will have a Bachelor’s degree and significant experience in the medical device industry...Medical device
- ...Senior Regulatory Affairs Specialist At EBR Systems, Inc., we are not imagining that future—we... ...leadless left ventricular endocardial pacing device for heart failure. It's a breakthrough... ...We don't just create game-changing medical devices—we grow people. Patients come...Medical device
- ...provides expert support for regulatory project management, strategic... .... Essential Job Duties • Lead global regulatory submissions... ...Mentor and coach regulatory affairs specialists. • Track and report... ...: Quality AssuranceExperience level: AssociateIndustry: Medical DeviceMedical deviceLocal areaWorldwideFlexible hours
- ...Summary The Sustaintment Leads leads the strategy, architecture... ...hardening of OT/IoT security devices.Build, mentor, and manage a... ...Ensure compliance with relevant regulatory and contractual requirements... ...level: AssociateIndustry: Medical Device...Medical deviceContract workFor contractorsWork at officeLocal areaWorldwideFlexible hours
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