Global Regulatory Submissions Specialist I
Penumbra
Penumbra, Inc. in Alameda, CA seeks a Regulatory Affairs coordinator to help bring life-saving technologies to patients worldwide by preparing and maintaining document packages for regulatory submissions. You will assist in preparing submissions (510(k), CE/UKCA, IDE, non-US trials, and foreign registrations), track multiple projects, and ensure documentation adheres to internal procedures and ISO 13485. Some travel (0–30%) may be required. #J-18808-Ljbffr Penumbra
$90k - $125k
Alameda, CAGeneral Administration - Regulatory Affairs /External /HybridIn this role, you will... ...packages for worldwide regulatory submissions.What You’ll Work On• Under direct supervision... ...in-country RA personnel to facilitate global clearance/approvals• Monitor, research,...SuggestedTemporary workWork at officeLocal areaWorldwide- BeOne Medicines seeks an experienced regulatory affairs professional to manage, evaluate, and complete regulatory projects aligned with company goals. The role plans and coordinates regulatory submissions, guiding cross-functional teams on strategy and tactics, and represents...Suggested
$100k - $200k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people... ...technology. The Opportunity The Principal RA Specialist will work on-site out of our Alameda,... ...responsibilities for leading global regulatory submissions, which include but not limited to...SuggestedShift work$100k - $200k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people... ...This Principal International Regulatory Operations Specialist will work on-site at our Alameda, CA... ...Coordinate with regional RA to update submission strategies and registration maintenance...SuggestedWorldwideShift work- Are you an experienced Regulatory Affairs professional with a passion... ...Regional Regulatory Affairs Specialist Northern Europe at Koppert... ...commercial stakeholders and Global Regulatory Affairs. You will... ...or reviewing regulatory submissions and authority responses Strong...SuggestedFull timeLocal areaRemote workWorldwideFlexible hours
- ...position will be responsible for supporting the maintenance of the Global Regulatory Affairs filing system and the Registration Tracking System (... ...such as ordering required certificates and tracking of submission under Health Authority review. Continued maintenance of...Work at officeImmediate start
$148.7k - $297.3k
...Abbott is a global healthcare leader that helps people live more fully at all stages of... ...Opportunity This Associate Director Regulatory Affairs will work on-site out of our... ...relevant data to complete a regulatory submission. Write and edit technical documents....WorldwideShift work- ...Years Experience: Must have 7 years of experiences in Medical Device Regulatory Affairs Considered as highly experienced with regulatory change assessments. Working knowledge in US Medical Device Submissions Participates in some of the following: continuous improvement...
- Abbott is a global healthcare leader seeking a senior portfolio leader to own the Compliance/UDI program portfolio, drive CAPA and regulatory initiatives, and guide on-market product changes. You will develop strategies, roadmaps, and ensure alignment with regulatory priorities...
$100k - $130k
Alameda, CAMarketing - Marketing Operations /External /HybridThe Global Project Manager will play a crucial role in coordinating and... ...operations team, global marketing managers, and Medical, Legal, and Regulatory (MLR) review teams. The Global Project Manager will be...Temporary workWork at officeLocal area3 days per week$195k - $277.5k
...PURPOSE: Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well... ...of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into...Full timeWork at officeLocal areaFlexible hours- ...Laboratories in Alameda, CA is seeking a Sr. Quality Specialist to lead complex quality and regulatory initiatives that impact patient safety and business... ...complaint assessments, regulatory reporting decisions, and submissions such as MDRs, MedWatch, and Vigilance, partnering...
$114k - $228k
...California - AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: 2026-08-04Abbott is a global healthcare leader that helps people live... ...provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions...$114k - $228k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live... ...executives, and scientists.The Opportunity This Regulatory Affairs Manager - APAC position will... ...support for compiling regulatory submissions, and ensuring data is effectively presented...Shift work- BRG is seeking a Workplace Project Manager to lead end-to-end office projects globally, from planning through occupancy. You will drive analyses in Excel, present executive updates in PowerPoint, review construction docs, and coordinate with architects, contractors, and...For contractorsWork at office
- Koppert seeks a Regulatory Affairs Specialist to secure and maintain market access for biological solutions across Northern Europe. You will work with Global Regulatory Affairs and country teams, develop strategies, manage registrations, and ensure compliance. This role...
- ...ideas and big dreams and become part of a global team of over 50,000 planners, designers,... ....Coordinate and track design submissions, submittals, Requests for Information (RFIs... ...tracking, and mitigation.Support permitting, regulatory coordination, utility coordination, and...For contractorsWork at officeLocal areaWorldwideFlexible hours
$90k - $180k
...United States - California - AlamedaJob Type: Full timeCategory: OperationsIndustry: HealthcarePosted Date: 2026-08-18Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum...Work experience placementWorldwide$268.5k - $380k
SUMMARY/JOB PURPOSE: The Executive Director, Regulatory Affairs has oversight for all regulatory... ...for developing and implementing global regulatory strategies encompassing clinical... ...preparation of organized and scientifically valid submissions. Provides expertise in translating...Work at officeLocal areaFlexible hours$248k - $352.5k
...Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well... ...of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into...Full timeContract workWork at officeLocal areaFlexible hours$285k - $405.5k
...pharmacokinetic, and drug metabolism strategies that support candidate selection, IND-enabling activities, clinical development, and global regulatory submissions.Oversee the design, conduct, monitoring, interpretation and reporting of GLP and non-GLP toxicology, safety pharmacology...Full timeWork at officeLocal areaFlexible hours$172k - $344k
...AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live... ...Compliance PM & ALD portfolio, including CAPA, regulatory compliance, labeling changes, on market... ...Managers, Project Managers, Labeling Specialists, and contingent workers.Foster...WorldwideShift work$156.08k - $195.1k
...insurance*Generous paid time-off policy (PTO), plus paid sick time, inclusive parental leave policy, holidays (including a year end Global Week of Rest), and volunteer days offRSU stock grants*Professional development and training opportunitiesCompany virtual happy...Full timeWork at officeRemote workFlexible hours$105k
...historical responses for consistency and accuracy in current submissions. Manage intake, logging, assignment, and tracking of data... ..., distribution, or transmission experience Knowledge of regulatory policy and compliance concepts, and/or risk management...Work at officeFlexible hours$114k - $228k
...Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies... ...& enhancement of analytics to support understanding of submissions. The position requires strong people management, analytical, prioritization...Work experience placementWorldwideFlexible hoursShift work$90k - $180k
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies... ..., variance analyses, financial commentary, and forecast submissions. Support quarterly business reviews, annual planning processes...Shift work$90k - $180k
...Alameda, United States of AmericaTime Type: Full timeAbbott is a global healthcare leader that helps people live more fully at all... ...operating expense forecasts and ensure accurate, timely financial submissions.Monitor spending against budget and forecast while maintaining...Shift work$90k - $180k
...Abbott is a global healthcare leader that helps people live more... ...: Sr. Quality Specialist Working at Abbott... ...to lead complex quality and regulatory initiatives that directly impact... ...decisions, and the preparation of submissions such as MDRs, MedWatch, and...WorldwideShift work$157.5k - $222.5k
SUMMARY/JOB PURPOSE: The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company’s submission portfolio, with first... ...submissions. She/he utilizes in-depth knowledge of global regulatory submission requirements and works...Full timeWork at officeLocal areaFlexible hours- Company DescriptionXinnovit is a global leader in technology consulting, outsourcing, and workforce management solutions.Our mission is to enable our clients to become more agile and competitive with the help of innovative technologies. We empower our clients to respond...
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