Global Regulatory Affairs Specialist - IVD Submissions
Lancesoft
LanceSoft is seeking a Regulatory Affairs Specialist in Fremont, CA to draft, assemble, and file regulatory submissions for new or existing products. You will ensure accuracy, high quality literature support, and compliance with applicable regulations, facilitating timely reviews. The role supports international registrations for IVD products, coordinating information, maintaining files, and preparing documents for submissions. Strong communication and regulatory knowledge are essential. #J-18808-Ljbffr Lancesoft
- LanceSoft is seeking a Regulatory Affairs Specialist II in Fremont, CA to draft, assemble, and file regulatory submission materials for new or existing products. The role focuses on international registration of IVD products and ensuring compliance with regulations and...Suggested
$33 per hour
...Hourly Position Summary The Regulatory Affairs Specialist will draft, assemble, and... ...original documentation and submission materials for new or existing... ...Registration of IVD products. Tasks will include... ...Our mission is to establish global cross-culture human connections...SuggestedHourly payPermanent employmentFull timeDay shift$160k - $190k
...Principal Global Regulatory Affairs Specialist Hayward, CA - Onsite Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine... ...implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (...SuggestedWork at officeLocal areaRelocationFlexible hoursNight shift$114k - $253k
...The group you'll be a part of The Global Operations Group brings information systems, facilities, supply chain, logistics, and... ...ensure compliance with global trade regulations while translating regulatory and leadership priorities into actionable plans that support...SuggestedLocal areaRemote workFlexible hours2 days per week3 days per week1 day per week$346.64k
...the patients across the world.As the Global Head of Regulatory Affairs, you enable and empower your team to... ...direction for Global Regulatory Submissions with leadership of teams in Europe,... ...success in the Regulatory arena and IVD field5-7 years leading and managing...SuggestedFull timeLocal areaRelocation package- Job Description Data Collections Analyst job at Insight Global. Fremont, CA. Job Description The Data Collection Analyst will collect data by controlling a robotic arm via teleoperation to perform the following tasks: Staging and setting-up equipment for the collection...Shift work
- ...an experiencedCE-IVDR Regulatory Consultantto lead and... ...development, clinical affairs, quality, manufacturing... ...studiesrequiredfor CE-IVDR submission. Review study... ...Minimum 8 years of IVD regulatory experience.... ...supporting US FDA and global regulatory submissions...Remote workFlexible hours
- A global technology services provider is seeking an Infrastructure Supply Chain Analyst to manage global asset management and optimize supplier performance. Key responsibilities include developing innovative logistics processes, analyzing metrics, driving automation, and...Work at office
$210k - $230k
Job Description:Director, Global Program Management (Power & Mechanical Systems)Role Summary Nextpower is seeking a Director, Global Program Management to lead the Program Management function within Supply Chain Strategy for Power & Mechanical Systems. This leader will...Full timeContract workWorldwide- ...server and data center solutions from NPI to mass production in Fremont, CA. You will own program schedules, manage risks, coordinate global teams, and drive on-time delivery of customer milestones while maintaining strong stakeholder alignment and accountability in a...
- ...budget delivery. The role requires experience in ESS, strong project management skills, and the ability to collaborate with manufacturing, sales, and logistics teams globally. Willingness to travel domestically and internationally is expected. #J-18808-Ljbffr Gotion Inc.Overseas
- ...Project/Program Manager in Milpitas, CA (Remote) to support global regulatory registration and labeling transitions within the Biosciences... ...across regions and product groups, coordinating across Regulatory Affairs, Quality, R&D, Labeling, Product, Operations, IT, and Supply...Remote job
- About Mattson Company: Mattson Technology, Inc., a 38-year Silicon Valley company, designs, manufactures, markets, and globally supports plasma and rapid thermal processing equipment to fabricate integrated circuits for the global semiconductor industry. Mattson Technology...Worldwide
- ...Project Artemis Focus Global registration and... ...execution for global regulatory registration and labeling... ...across Regulatory Affairs, Quality, R&D, Labeling... ...remediation activities, and submission-related dependencies... ...medical device or IVD registrations, re-registrations...Remote workShift work
- EOS IT Solutions is seeking a Program Coordinator to support global logistics operations, order control, and program execution. You will coordinate between internal teams, 3PLs, warehouses, and stakeholders to ensure successful delivery of logistics programs and initiatives...Remote work
- EOS IT Solutions is seeking a Program Coordinator to support global logistics operations, order control, and program execution. You will act as the central point between internal stakeholders, logistics providers, warehouses, and cross-functional teams to ensure successful...Remote work
- Hunter Hamilton seeks an experienced Trade Compliance Classification Specialist to support U.S. import compliance and FTZ activities. The role focuses on HTS classification for products, reviewing technical docs, and applying CBP rulings and tariff guidance. The ideal...
- Staffmark Group is seeking an experienced Trade Compliance Classification Specialist to support U.S. import compliance and FTZ activities in a technology-driven manufacturing environment. You will analyze HTS classifications, review technical drawings, and apply CBP rulings...
$38 - $41 per hour
...Company Overview Milestone Technologies is a global IT managed services firm that partners with organizations to scale their technology... ...all IT-related incidents and service requests. The IT Support Specialist is responsible for providing technical assistance and support...Hourly payFull timeTemporary workWork at officeLocal areaRemote workWorldwide$106.1k - $197k
...makes us Roche. As an International Regulatory Affairs Manager you will be a member of the CDx... ...delivery of high quality regulatory submissions of IVDs (including companion diagnostics) to... ...international requirements and directly support global submissions by managing data,...Full timeLocal areaWorldwideRelocation package- Pivotal Systems is seeking an Order Output Manager to drive predictable order execution across a global manufacturing environment. You will partner with Planning, Operations, Supply Chain, Manufacturing, and Quality to provide end-to-end visibility into order status, material...
$121.9k - $167.64k
...winning vehicles bring our “Compromise Nothing” approach to the global automotive market. That means refusing to choose between... ...requests and is not monitored for job applications or resume submissions. To be considered for employment, all applications must be submitted...Hourly pay$151.7k - $222.42k
...OneSource Tax, OpenText VIM, SAC, and Anaplan. Familiarity with global deployments and multi-country finance operations. Knowledge... ...requests and is not monitored for job applications or resume submissions. To be considered for employment, all applications must be...Hourly payFor contractors$132k - $200k
...a lasting impact on industries that power the world’s most dynamic markets. Location: Fremont, CA Reports To: Director Global Accounts Executive Salary Range: $132,000-$200,000 Position Summary: We are a rapidly expanding manufacturing company...Shift work$136k - $162k
...how often (in days) to receive an alert: Category: Regulatory Affairs Quality Assurance Location: Union City, CA, US, 945... ...are seeking an experienced Distribution Compliance Specialist to oversee and ensure global regulatory compliance for the distribution of our Class...Work at officeLocal area$225k - $250k
...CROs, and the manufacture/distribution of commercial products globally. This role will also be responsible for leading science-... ...Establish and adhere to all quality agreements.Provide support for regulatory submissions.Manage regulatory agencies (FDA, EMA), and state board...Contract workFor contractorsLocal areaFlexible hours3 days per week$140k - $155k
Job Description:The Global Sales Operations Training & Process Analyst is responsible for training, coaching, and supporting Global Sales Analysts to ensure consistent execution of global sales operations processes and best practices. This role supports the daily execution...Full timeWork at officeWorldwide- Security Industry Specialists, Inc. in Fremont, CA is seeking a Protective Service Operator / Analyst to monitor global threats for personnel, property, and client reputation within the GSOC. You will analyze open-source feeds, determine escalations per SOP, and produce...
$180k - $225k
...attempting to just fill another job, but to pursue a dream of global green energy together! We offer outstanding opportunities to individuals... ...~ Knowledge of federal and state renewable energy incentives, regulatory policies, and market dynamics. ~ Excellent negotiation,...- ...with Digital Transformations across various domains and industries. Our history spans over 19 years and today we are an Award-Winning Global Software Consultancy solving complex problems with technology. We recognize that our employees and our clients are our strengths as...Work at office
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