Senior Regulatory Affairs Lead - Medical Devices (Hybrid)
System One
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 leadership. The ideal candidate will drive regulatory plans, author pivotal documents such as 510(k) submissions, and coordinate with international teams to support global approvals. Hybrid work with onsite days is offered. #J-18808-Ljbffr System One
- System One is seeking a Regulatory Affairs Specialist IV in Sunnyvale, CA for a... ...6-month contract. The role is hybrid (3 days onsite) with a 40-hour... ...strategy and global submissions for medical devices across the US, Canada and beyond. You will lead FDA 510(k) submissions,...SeniorMedical deviceContract work
- 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
- ...approach. Working with top medical professionals, they... ...challenges worldwide. Position Senior Regulatory Affairs Specialist (Contract Basis) - Hybrid (3 days on‑site, 2 days... ...changes. Influence and lead global regulatory... ...in a medical device environment. Strong understanding...SeniorMedical deviceContract workFor contractorsRemote workWorldwide2 days per week
- 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...SeniorMedical device
- BioRobotics is looking for a Principal Regulatory Affairs Specialist to provide regulatory leadership from product development through marketing... .... The role requires a minimum of 12 years in the medical device industry, with strong knowledge of regulatory standards and...SeniorMedical device
- ...is looking for a Principal Regulatory Affairs Specialist to spearhead complex... ...strategies for Class III devices. This role involves authoring... ...submissions, ensuring compliance for medical devices, and mentoring... .... The position offers a hybrid work culture, allowing flexibility...SeniorMedical device
- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead in Santa Clara, CA. This role involves leading regulatory strategies... ...6 years of experience in regulatory affairs within medical devices, strong analytical skills, and excellent communication...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
$90k - $180k
Abbott is seeking a Senior Regulatory Affairs Specialist in Santa Clara, CA to provide regulatory input across the product lifecycle and support... ...from $90,000 to $180,000 and excellent benefits including medical coverage, retirement savings plans, and educational reimbursements...SeniorMedical device- EBR Systems, Inc. is seeking a Senior Quality Engineer to join cross-functional teams for product specification... ...validations, risk analysis, and human factors. Lead CAPA and ensure compliance with QMS and regulatory requirements. You will support production, troubleshoot...SeniorMedical deviceContract work
- A leading staffing company is seeking an experienced regulatory professional for their Companion Diagnostics team. The ideal candidate will have extensive global regulatory experience in IVDs and medical devices, leading successful submissions and working directly with...SeniorMedical device
$109k - $174.8k
...United States of America Position Senior Regulatory Affairs Program Lead - Instrumentation & Accessories Preferred... ...feedback for specifications, device testing, risk management, and related... ...Regulatory Affairs experience within Medical Device (4+ years with Advanced Degree...SeniorMedical deviceLocal areaImmediate start- ...robotics firm in Sunnyvale is seeking a Senior Clinical Engineer who will develop... ...robotic solutions for the medical industry. The role includes leading cross-functional teams, overseeing... ...years of experience in the medical devices sector and a strong educational background...SeniorMedical device
- Intuitive is looking for a Senior Project Manager, PMO in Sunnyvale, California. The role involves leading cross-functional teams to deliver innovative medical device products with a focus on project management and strategic alignment. Candidates should possess a BS degree...SeniorMedical device
$138k - $154k
Ceribell │ Point-of-Care EEG in Sunnyvale, California is seeking a Senior Electrical Engineer. In this role, you will support the design of next-generation medical devices, engaging in all stages of electrical design and ensuring compliance with quality standards. Ideal...SeniorMedical device- Ford Motor Company in Palo Alto is looking for a Senior Software Engineer to join their Electric Vehicles, Digital and Design (EVDD) team... ...in Java and Kotlin. This role offers excellent benefits, a hybrid work arrangement, and a competitive salary range. #J-18808-Ljbffr...Senior
- Namely is seeking a Senior Hybrid Business Development Representative to own the top of funnel pipeline generation for the Japan region. This role is ideal for individuals with a proven track record in high-volume outbound business development and fluency in both Japanese...SeniorFlexible hours
- EY is seeking a Senior Technology Analyst to work with Oracle Services in Palo Alto. You will support complex lifecycle initiatives in... ...or Cloud. Enjoy a comprehensive benefits package with options for flexible vacation and hybrid working arrangements. #J-18808-Ljbffr EYSeniorFlexible hours
$145k - $167k
...Senior Regulatory Affairs Specialist Palo Alto, CA - Hybrid Hyperfine, Inc. is the groundbreaking health... ...for the company's devices and ensures compliance... ...and leadership. Lead the preparation of all... ...Strong knowledge of medical device labeling requirements...SeniorMedical deviceWork experience placementWork at officeWorldwideWork visaNight shiftWeekend work3 days per week- Fiddler AI in Palo Alto is seeking a Senior Recruiter to enhance their recruitment processes and lead hiring initiatives for a high-growth tech environment. The ideal... ...offers competitive compensation and benefits, along with a hybrid work model. #J-18808-Ljbffr Fiddler AISenior
- ...California is seeking a Principal Regulatory Affairs Associate for their health... ...team. This role involves leading regulatory initiatives to... ...approvals for innovative medical devices, requiring 10+ years of medical... ..., and participate in a hybrid work environment. Join Apple...Medical device
- A leading medical technology company seeks a Quality Engineer in Sunnyvale, California. The role involves driving quality initiatives for... ...years in Quality Engineering and a passion for improving medical device performance. This position offers the opportunity to...SeniorMedical device
- IntelliPro seeks a Senior Manager SEC Reporting in Palo Alto with a hybrid schedule for a long-term contract. The role emphasizes SEC filings (10-Q/10-K), XBRL tagging, and SBC disclosures, reporting to finance leadership. You will own or support 10-K/10-Q processes, ASC...SeniorLong term contract
- 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... ...FDA submissions. This hybrid role is essential for...Medical device
$146.3k - $244.1k
...together, committing to the values that lead to great work. Every new product... ...Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate... ...audit program to ensure ongoing regulatory compliance and encourage continuous...SeniorMedical deviceRelocation$180k - $200k
A leading health technology company 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... ..., strong regulatory knowledge, and excellent...SeniorMedical device- Job Title: Sr. Regulatory Affairs Location: Sunnyvale, CA - Hybrid Duration: 06 Months Onsite: Onsite 3 Days Per Week... ...facility changes. Influence and lead global regulatory strategies. Author... ...affairs experience working in a medical device company (can be in combination...SeniorMedical device3 days per week
$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 competitive...SeniorMedical device- Imperative Care is seeking a Senior Manager in Design Assurance located in Campbell... ...in ensuring compliance with regulatory standards and leading quality-focused initiatives across... ...in Quality and Design Assurance in medical devices, a Bachelor’s degree in Engineering...SeniorMedical device
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead - Medical Devices (Hybrid). Be the first to apply!
- senior app developer Mountain View, CA
- senior international account manager Mountain View, CA
- senior product manager mobile Mountain View, CA
- senior magento developer Mountain View, CA
- senior quantitative risk analyst Mountain View, CA
- sr marketing manager Mountain View, CA
- sr technical product manager Mountain View, CA
- senior manager pmo Mountain View, CA
- senior accountant part time Mountain View, CA
- senior electrical designer Mountain View, CA

