Senior Regulatory Affairs - Medical Devices (Hybrid)
Creative Solutions Services, LLC
Creative Solutions Services, LLC in Sunnyvale, CA is seeking a Sr. Regulatory Affairs professional with over 8 years of experience in medical devices. This role involves developing regulatory plans, preparing submissions, and ensuring compliance with U.S. and Canadian regulations. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and a willingness to collaborate with teams. Candidates with a B.S. or higher in relevant fields are preferred, as well as those holding RAPS certification. #J-18808-Ljbffr Creative Solutions Services, LLC
- BBG Ventures, LLC is seeking a Senior Regulatory Affairs Specialist to join their team in Sunnyvale, CA on a hybrid basis (3 days on-site, 2 days remote). The ideal candidate... ...of regulatory affairs experience in the medical device sector and a strong understanding of U.S....SeniorMedical deviceFor contractorsRemote work
- 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... ...international teams to support global approvals. Hybrid work with onsite days is offered. #J...SeniorMedical deviceContract work
- ...open approach. Working with top medical professionals, they continue to... ...challenges worldwide. Position Senior Regulatory Affairs Specialist (Contract Basis) - Hybrid (3 days on‑site, 2 days remote per... ...affairs experience in a medical device environment. Strong understanding...SeniorMedical deviceContract workFor contractorsRemote workWorldwide2 days per week
- ...Mechanical Engineer to advance core research and development of a medical EEG platform. You will design, test, and document mechanical... ...and collaboration with vendors and test labs in a regulated environment, with hybrid work in Sunnyvale. #J-18808-Ljbffr Ceribell, IncSeniorMedical 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...SeniorMedical device
- ...pioneering robotics firm in Sunnyvale is seeking a Senior Clinical Engineer who will develop innovative robotic solutions for the medical industry. The role includes leading cross-... ...5-10 years of experience in the medical devices sector and a strong educational background...SeniorMedical device
- Abbott Laboratories is seeking a Principal Regulatory Affairs Specialist for the Vascular division, working on-site in Santa Clara, CA... ...through commercialization. The role requires 6-8 years in medical devices, experience with Class II/III devices, and strong collaboration...SeniorMedical 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...SeniorMedical deviceWorldwide
- System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, California to lead regulatory strategy and submissions for medical devices across the U.S., Canada, and global markets. You will support product development, design changes, lifecycle management, and...SeniorMedical device
- A leading staffing company is seeking an experienced regulatory professional for their Companion Diagnostics team. The ideal candidate... ...have extensive global regulatory experience in IVDs and medical devices, leading successful submissions and working directly with regulatory...SeniorMedical device
- Job Title: Sr. Regulatory Affairs Location: Sunnyvale, CA - Hybrid Duration: 06 Months Onsite: Onsite 3 Days Per Week Primary Function of Position The... ...years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory...SeniorMedical device3 days per week
$125k - $145k
...Responsibilities Assess and advise regulatory strategies to optimize... ...registrations and device listing per applicable... .... Strong knowledge of medical device labeling... ...in Regulatory Affairs role. Experience interpreting... ...Demands This is a hybrid role based out of Hyperfine...SeniorMedical deviceWork experience placementWork at officeWork visaNight shiftWeekend work3 days per week$90k - $180k
...healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000... ...software, vessel closure devices and peripheral stents. Senior Regulatory Affairs Specialist This onsite opportunity is located in our...SeniorMedical deviceWork experience placementWorldwide- ...Sr. Regulatory Affairs Specialist We are searching for an experienced regulatory professional to work within the Companion Diagnostics... ...must have global regulatory experience working in IVD, Medical Devices or Pharmaceutical, with a history of successful regulatory...SeniorMedical device
$180k - $200k
...in Mountain View, CA, is seeking a Senior Quality Engineer to implement and maintain quality systems for medical devices and consumer products. This hybrid role involves ensuring compliance... ...device quality engineering, strong regulatory knowledge, and excellent...SeniorMedical device$180k - $200k
Willow-Innovations is seeking a Senior Quality Engineer for its... ...implementing quality systems for medical devices, driving design assurance, and ensuring compliance with regulatory standards such as ISO 13485... ...analytical skills. This hybrid position offers a salary range...SeniorMedical device$180k - $200k
A leading medical device company is looking for a Senior Quality Engineer to ensure compliance with industry standards like ISO 13485 and lead quality assurance... ...and a degree in a relevant engineering field. This hybrid position is based in Mountain View, CA, with a...SeniorMedical device- Intuitive in Sunnyvale, California is seeking a Senior Manager, Embedded Software Engineering to lead a team in developing innovative electrosurgery products. This role emphasizes managing the full software development lifecycle, ensuring compliance with industry standards...SeniorMedical device
- ...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 authorization...SeniorMedical device
- Shockwave Medical is seeking a dedicated Senior Quality Engineer in Santa Clara, CA, to provide Design Quality Assurance for medical device designs and ensure compliance with industry regulations... ...include process improvements, regulatory documentation, and enhancing quality...SeniorMedical device
- TruLegal (formerly TRU Staffing) is seeking a Senior Employment Counsel to provide practical employment law guidance across the organization... ...and the opportunity to work in a dynamic workplace culture in a hybrid environment. #J-18808-Ljbffr TruLegal (formerly TRU Staffing)Senior
- EBR Systems, Inc. is seeking a Senior Quality Engineer to join cross-functional teams for product specification development and quality... ...human factors. Lead CAPA and ensure compliance with QMS and regulatory requirements. You will support production, troubleshoot issues...SeniorMedical deviceContract work
- ...alignment, and support verification and reliability testing in a hybrid work setting requiring 3-5 days onsite. You should have a... ...production, and hands-on CAD (SolidWorks) and FEA, with familiarity in medical device design controls. #J-18808-Ljbffr Ceribell │ AI-Powered Point-...Medical device
- ...Cupertino, California is seeking a Principal Regulatory Affairs Associate for their health products... ...to obtain approvals for innovative medical devices, requiring 10+ years of medical device... ...filings, and participate in a hybrid work environment. Join Apple to impact...Medical device
$35 - $46 per hour
Cirtec Medical is seeking a Quality Support Engineer in Santa Clara, California. This role focuses on assisting quality engineers with... ...quality issues in production and ensuring compliance with medical device regulations. The ideal candidate will have a background in...SeniorMedical deviceHourly pay$227k - $307k
Intuit is looking for a Senior Employment Counsel to provide legal counsel on complex workforce matters. You will partner with People &... ...compliance and support the company's employment strategy. The role is hybrid with on-site expectations in Mountain View or San Diego,...Senior- ...The client seeks a Principal Regulatory Affairs Specialist to lead complex... ...submissions for Class III implantable devices and software-driven... ...Ensure compliance for Class III medical devices, including software-... ...to work on-site in a hybrid model (4 days per week). EOE...Medical device
$228k - $279k
...Android applications. This role requires a strong focus on user experience and a solid understanding of mobile issues. The position is hybrid, with in-office work required 2 days a week, and offers a competitive salary range of $228,000-$279,000, plus equity and benefits....SeniorWork at office2 days per week- ...Senior Regulatory Affairs Specialist Tiposi Tiposi is developing Dragonfly, a portable microwave-based brain scanner for rapid stroke detection... ...Conformity as needed Track and interpret evolving global medical device regulations and translate them into actionable guidance...SeniorMedical device
- Eightelevengroup is looking for a Senior Technical Project Manager for a QMS transformation initiative in Santa Clara, CA. This hybrid role involves overseeing the transition from legacy... ...standards. Benefits include competitive medical coverage, paid time off, and a 401k plan...Senior
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