Global Regulatory Affairs Specialist - IVD Submissions
LanceSoft Inc
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
- US Tech Solutions in Fremont, CA seeks a Regulatory Affairs Specialist II to draft and file regulatory submissions for IVD products and support international registrations.... ...technical files for CE marking and coordinate with global teams to obtain approvals and renewals. The...SuggestedContract work
- ...Position Summary ~ The Regulatory Affairs Specialist II will draft, assemble, and... ...original documentation and submission materials for new or existing... ...Registration of IVD products. Tasks will include... ...US Tech Solutions is a global staff augmentation firm providing...Suggested
$114k - $253k
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- ...an experiencedCE-IVDR Regulatory Consultantto lead and... ...development, clinical affairs, quality, manufacturing... ...studiesrequiredfor CE-IVDR submission. Review study... ...relatedfield. Minimum 8 years of IVD regulatory experience.... ...supporting US FDA and global regulatory submissions...Remote workFlexible hours
- ...Executive Director, Regulatory Affairs About the Company Innovative pharmaceutical company... ...in developing and executing global regulatory strategies for a diverse product... ...intelligence, and overseeing the preparation and submission of major regulatory filings....
$210k - $230k
Director, Global Program Management (Power & Mechanical Systems)Skip to main content#Director, Global Program Management (Power & Mechanical Systems) page is loaded## Director, Global Program Management (Power & Mechanical Systems)Applylocations: Fremont, South Bldg, California...Contract workWorldwide- ...Technology Trade Compliance SpecialistMattson 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....Worldwide
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$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...Full timeLocal areaRelocation package- ...with Digital Transformations across various domains and industries. Our history spans over 16 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...
$62.14 per hour
...effectiveness of customer support and self-service experiences. Why You'll Love Working Here: Play a critical role in supporting global knowledge management initiatives. Work closely with cross-functional teams across customer support, operations, and business...Contract workWork experience placementWork at officeWorldwide$140k - $155k
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- ...that support evolving business priorities and organizational transformation. Talent Acquisition & Workforce Planning Lead global talent acquisition strategies to attract exceptional technical, manufacturing, and corporate talent. Develop workforce planning...Local area
$210k - $250k
...processes necessary for scaling the company Drive change management initiatives to support evolving business priorities Lead global talent acquisition strategies to attract exceptional talent Champion a culture of collaboration, accountability, and innovation...Visa sponsorship- Trade Compliance Analyst The Trade Compliance Analyst will support in the development and implementation of the company's Export Compliance Program ensuring adherence to EAR, ITAR, OFAC, and U.S. Customs regulations. This is a hybrid position near Fremont, CA. ...
- ...including adherence to C-TPAT, EU AEO, and other internal/external regulatory requirements based on customer needs. Responsible for Free... ...Knowledge / Skill & Abilities: Certified Customs Specialist is highly preferred. Strong written and oral communication...Shift work
- ...Senior Compliance AnalystAmpcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented team. Location(s): Pleasanton, CA.Role OverviewThe Sr. Compliance...Work at office
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...Manager, Regulatory Affairs Pleasanton, CA Noctrix Health is redefining the... ...wearables. Our team of medical device specialists, neuroscientists, and consumer... ...regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post...Full time$230k
...Job Summary Manages all regulatory activities for the company. Develops and implements... ...valid regulatory documents and submissions. Provides expertise in translating regulatory... ...pharmaceutical industry with direct regulatory affairs experience with drug/device combination...$212.5k - $250k
...confidence of patients, the global healthcare community, collaborators... ...in the role of Director for Regulatory CMC directly reporting to... ...in advancing CMC strategy and submissions of developmental, life cycle... ...Job Details Job Family R&D Job Function Regulatory Affairs...For contractorsLocal area3 days per week
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