Global Regulatory Submissions Specialist I
Penumbra, Inc.
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, Inc.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Submissions Specialist I in Alameda, CA vacancy
- Penumbra, Inc. is seeking a Regulatory Associate to prepare and maintain documentation for worldwide regulatory submissions, ensuring approvals across regions. You will coordinate between teams and regulatory agencies to support clinical research, export, and commercial...SuggestedWorldwide
$77k - $98k
...preparation, and maintenance of document packages for worldwide regulatory submissions. What You’ll Work On Under direct supervision, assist in... ...procedures Support in-country RA personnel to facilitate global clearance/approvals. Research and obtain information on Regulatory...SuggestedTemporary workWork at officeLocal areaWorldwide$90k - $180k
...AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: Abbott is a global healthcare leader that helps... ...Senior Regulatory Affairs Specialist will support product... ...of documentation to support submission activities to meet program objectives...Suggested$100k - $200k
## Principle Regulatory Affairs Specialist - Diabetes Care (on-site)Applylocations: United States - California... ...requisition id: 31151822Abbott is a global healthcare leader that helps people... ...with responsibilities for US submissions for new product introductions, which...SuggestedWorldwideShift work- Abbott is a global healthcare leader improving lives through diagnostics, medical devices, nutritionals and branded medicines. This role... ...leads the global Compliance PM & ALD portfolio, driving CAPA, regulatory changes, labeling updates, and UDI initiatives with cross-...SuggestedWorldwide
- Exelixis, a leader in oncology, seeks an Executive Director, Regulatory Affairs to guide global regulatory strategies from early development through... ...oversee program leaders, ensure timely IND/NDAs/BLAs submissions, and maintain strong FDA relationships to accelerate...
- ...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
- 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...
- Clinical Alameda, California Contract Aug 10, 2026 Senior Regulatory Affairs Specialist - Medical Devices Location: Alameda, CA Schedule: Full-... ...in regulatory change assessments and U.S. medical device submissions . This individual will serve as a regulatory subject...Full timeContract work
- ...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...
$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...WorldwideShift 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
$250k - $285k
...Travel Required: 20% Reports To: SVP, Regulatory Affairs Department: Regulatory... ...experienced regulatory affairs leader with deep global early and late-stage development... ...regulatory plans, address risks, and support submission readiness and potential approvals....Full timeBioSpace, Inc.
Emeryville, CA5 days ago- Abbott in Alameda, CA is seeking a finance professional to join the ADC Global Operations Finance team. This onsite role focuses on reporting, variance analysis, forecasting, and process improvements to support monthly closes and planning cycles. You will develop tools...
- ...MEG staff, ensure timely vigilance reporting, and coordinate with multiple groups to maintain compliant medical device reporting globally. The role requires a science/medical degree and 4+ years of relevant experience, with staff leadership a plus. Abbott offers comprehensive...
$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- Abbott Diabetes Care seeks a Senior Financial Analyst to partner with Global Headquarters Commercial leaders on strategic financial planning, forecasting, and investment decisions. This highly visible role influences performance and provides actionable insights across...
- Abbott is seeking a senior portfolio leader to drive the Global Strategic Initiatives PMO. You will own governance, prioritization, and... ...tools, and marketing roadmaps. You will partner with BTS/IT, Regulatory, Quality, and Commercial teams to ensure alignment with strategic...
- Abbott Diabetes Care in Alameda, California is seeking a Sr. Financial Analyst to support Global Third-Party Manufacturing Operations. You will partner with finance, operations, engineering and manufacturing teams to deliver insights that drive performance and strategic...
- ...design, benefits, compliance, and HRIS. You will partner with the CEO and executive team to shape workforce strategy, manage headcount, ensure compliance, and optimize global employment infrastructure using an Employer of Record model. #J-18808-Ljbffr Slingshot Biosciences
$148.7k - $297.3k
...California - AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: 2026-07-10Abbott is a global healthcare leader that helps people live... ...of relevant data to complete a regulatory submission.Write and edit technical documents.Recruit,...Worldwide$90k - $180k
...LaboratoriesLocation: United States - California - AlamedaJob Type: Full timeCategory: OperationsIndustry: HealthcarePosted Date: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the...Work experience placementWorldwide$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 hoursAbbott Laboratories company
Alameda, CA2 days ago$169.22k - $253k
Otsuka Pharmaceutical Co., Ltd is seeking a Director, Global Product Quality to lead the quality oversight of clinical and commercial products. This role ensures compliance with regulatory standards and collaborates across teams to maintain effective Quality Systems. The...$158k - $227k
...Management, Scientific Communications, Regulatory Medical Writing, and Clinical Study Management... ...studies, publications, and regulatory submissions. The role drives programming standards,... ...System (QMS) as well as domestic and global quality system regulations, standards, and...Temporary workFor contractorsWork at officeLocal area- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases... ...candidate will be responsible for defining and executing global regulatory strategy to support the development, registration, and...
$90k - $180k
...Abbott is a global healthcare leader that helps people live more... ...160 countries. Sr. Quality Specialist Working at Abbott At Abbott,... ...to lead complex quality and regulatory initiatives that directly impact... ..., and the preparation of submissions such as MDRs, MedWatch, and...WorldwideAbbott Laboratories company
Alameda, CA4 days ago- ...Ability to manage competing priorities in a fast-paced environment. Preferred Qualifications Experience supporting audit, compliance, regulatory, or risk management functions. Experience in preparing executive-level reports and presentations. Experience with Power BI,...2 days per week1 day per week
Spectraforce Technologies
Oakland, CA5 days ago $87k
...assessment, analysis, compliance reporting, and program metrics. Develops and implements PG&E's internal compliance framework for various regulatory standards. Collaborates with Subject Matter Experts and Standard Owners to develop processes and controls to ensure the...Work at officeLocal areaRemote workNight shift2 days per weekPG&E Corporation
Emeryville, CA4 days ago$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 workAbbott Laboratories company
Alameda, CA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Submissions Specialist I. Be the first to apply!
Related searches
- regulatory specialist Alameda, CA
- compliance officer Alameda, CA
- coding compliance specialist Alameda, CA
- aml compliance analyst Alameda, CA
- compliance analyst Alameda, CA
- medicare compliance specialist Alameda, CA
- regulatory officer Alameda, CA
- research compliance officer Alameda, CA
- regulatory analyst Alameda, CA
- regulatory compliance associate Alameda, CA