Global Regulatory Affairs Leader - Medical Devices
Pulse Biosciences, Inc.
Pulse Biosciences, Inc. is seeking a Principal Global Regulatory Affairs Specialist in Hayward, CA. The role leads global regulatory strategies for general, cardiac, and dermatology medical devices, coordinating with cross-functional teams and regulatory authorities. You will drive submissions, ensure compliance with EU MDR, ISO 13485, and FDA requirements, and oversee post-market activities while supporting product lifecycle from development to approval. #J-18808-Ljbffr
- ...Pulse Biosciences is seeking a Principal Global Regulatory Affairs Specialist in Hayward, CA (onsite). You will drive global regulatory strategy for general, cardiac, and dermatology medical devices, coordinating submissions to FDA and EU authorities and ensuring compliance...Medical device
- ...Pulse Biosciences is seeking a Principal Global Regulatory Affairs Specialist to lead regulatory strategy for general and cardiac surgery, as well as dermatology devices, across global markets. You will guide cross-functional teams through FDA QSR, EU MDR, and ISO 134...Medical device
$160k - $190k
...environment to our diverse workforce.About the RoleThe Principal Global Regulatory Affairs Specialist will be responsible for regulatory activities... ...in general surgery, and cardiac surgery and dermatology medical devices in targeted global markets. She/he provides leadership in...Medical deviceWork at officeRelocationFlexible hoursNight shift- ...Abbott is hiring a Regulatory Affairs Manager to lead U.S. regulatory strategy for new products and lifecycles, while mentoring a team of regulatory professionals across R&D, quality, and commercial teams in Alameda/Milpitas/Austin. The role emphasizes interaction...Medical device
- LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications with regulatory agencies, and ensuring compliance with evolving regulations...Medical device
$23.77 per hour
...new technology platformsAbout UsFounded in 2009, Stratosphere Quality is a global leader in quality inspection and assurance services, supporting manufacturers across automotive, medical device, electronics, and more — with operations in the U.S. and worldwide.Apply TodayStart...Medical deviceWork at officeWorldwide- ...Mattson Technology, Inc. is seeking a Global Logistics Manager to lead end-to-end international and domestic logistics operations from its Silicon Valley roots in Fremont, CA. You will own the global transportation strategy, compliance, and 3PL performance to ensure on...
- ...Abbott Laboratories seeks a Senior Regulatory Affairs Specialist for Lingo in Alameda, CA. You will support regulatory activities for Class II software medical devices, collaborating with product teams to ensure compliant submissions and labeling throughout development...Medical device
- ...Company Stark Pharma Solutions Inc. is a global consulting and staffing partner... ...in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the... ...solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project...Medical device
- Hyve Solutions is seeking a seasoned Compensation Leader in Fremont, CA to design and manage global compensation programs. You will oversee job architecture... ...structures, and governance, ensuring pay equity and regulatory compliance. The role partners with HRBPs, Finance,...
- ...Quality to lead and standardize quality systems across all facilities in the United States. This role will develop and execute the global quality strategy, improve customer quality performance, support product transfers and facility startups, and build a strong culture...
- Lam Research in Fremont, CA seeks a Product Regulatory Compliance Engineer to drive Lam's global regulatory compliance strategy for semiconductor manufacturing... ..., Product Management, Legal, and Government Affairs to ensure compliant product development and lifecycle...
- ...Company Stark Pharma Solutions Inc. is a global consulting and staffing partner... ...in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the... ...solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project...Medical device
- ...Abbott is seeking a Regulatory Affairs Manager – APAC in Alameda, CA to lead a regulatory team... ...Diabetes Care products. You will develop global regulatory strategies, collaborate... ...communication skills, regulatory experience in medical devices or diagnostics, and ability to...Medical device
$100k - $200k
Location United States - California - Alameda Category Regulatory Affairs Abbott is a global healthcare leader that helps people live more fully at all stages... ...leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our...Medical deviceLocal area- Abbott in Alameda, CA is seeking an Associate Director Regulatory Affairs to shape global regulatory strategies across the product life cycle in Diabetes Care. We focus on innovative glucose monitoring technologies and drive strategic regulatory initiatives. You will lead...Medical device
- GForce Life Sciences is seeking a seasoned Project Manager to serve as the primary liaison across project owners, teams, and management, communicating achievements, challenges, and escalation points. The role leads project execution, manages scope, timeline, and quality...Medical device
- ...market and launch strategy, positioning, and multi-year plan. The ideal candidate has launched Class III PMA devices in the US and can lead both HCP and direct-to-consumer programs in a fast-paced, pre-commercial environment, working with regulatory, #J-18808-Ljbffr...Medical device
- ...company, is seeking a Senior Manager, Operational Technology Programs & Operations Excellence to lead strategic OT initiatives across global manufacturing sites in Sunnyvale, CA. This on-site role bridges Operations, Engineering, and IT to translate business needs into...
$168.9k - $281.7k
...educational attainment and/or training.Director, Global Practice Lead — PI Data Infrastructure &... ...) is looking for a proven practice leader to own and scale our PI Data... ...secondary parental leave, well-being support, medical, dental, vision, and 401K.It’s possible we...Full timeWork at officeLocal areaRemote workWorldwideFlexible hours$90k - $125k
...Regulatory Affairs Specialist II at Penumbra prepares and maintains regulatory submission documentation for medical devices across global markets. The role involves coordinating approvals for clinical research and commercial distribution while ensuring compliance with...Medical device- ...engineers, and delivers an advanced energy technology platform for solar power plants. We are seeking an experienced Marketing Manager, Global Events to lead our global event strategy, planning, and measurement, collaborating with Product Marketing, Sales, and executive...
$114k - $228k
...type: full timeCategory: Regulatory AffairsIndustry:... ...can qualify for free medical coverage in our Health... ...Opportunity This Regulatory Affairs Manager – APAC... ...region, creating robust global regulatory strategies,... ...prepare, and review medical device or IVD submissions to...Medical device- ...Post-Market Surveillance (PMS) Analyst - Medical Devices Job Title: Post-Market Surveillance... ...Technology Department: Quality Assurance / Regulatory Affairs Experience: 2-5 years (adjustable)... ...with EU MDR, FDA MDR, and applicable global vigilance requirements. Familiarity with...Medical device
- ...to own the Quality Management System (QMS) across medical device/IVD products. You will lead regulatory compliance, audits, CAPA, change control and documentation... ...; partner with R&D, Operations and Regulatory Affairs to embed quality at every stage of the product...Medical device
$114k - $228k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live more fully... ...and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...teams, working with R&D, Regulatory Affairs, Quality Assurance and Marketing in...Medical deviceWork experience placementShift work- ...Lucid Motors seeks a seasoned Sr. level Global Supply Chain Manager to craft and execute procurement strategies for materials in our battery enclosure systems. You’ll partner with Engineering, Finance, Logistics, Quality, and Manufacturing to deliver world-class products...
$114k - $228k
...type: full timeCategory: Regulatory AffairsIndustry: HealthcarePosted... ...: 2026-10-05 Abbott is a global healthcare leader that helps people live... ...products in diagnostics, medical devices, nutritionals and branded... ...technology. This Regulatory Affairs Manager position is an...Medical deviceWork experience placement$330k
...The VP, Quality & Regulatory Affairs is an executive leadership... ...functions. This executive leader provides strategic and... ..., EMA, ICH, and other global regulations to meet... ...experience with drug/device combination products.... ...regulated pharmaceuticals, medical devices or drug...Medical device- Overview We are partnering with a growing, innovative medical device organization seeking a Senior Regulatory Affairs Specialist to support global regulatory strategy, submissions, and product lifecycle activities. This is a high-impact opportunity to work cross-functionally...Medical deviceLocal area
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