senior regulatory affairs specialist Jobs in san francisco, ca

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Sr. Regulatory Affairs Specialist

APN Software Services, Inc

Palo Alto, California, USA

Contract

Please contact Abdul on "" OR email me at "" *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements * Identifies, analyzes and implements country specific requirements necessary for product related submissions. *Recommend strategies for earliest possible approvals for marketing applications * Performs regulatory projects or acts as a member of the project steering group. * Submits required documentat

Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

Remote

Contract

Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities: -Authoring US FDA 510(k) submission using eSTAR submission tool.

Regulatory Affairs Specialist III

Fusion Life Sciences

Remote

Contract

Job Title: Regulatory Affairs Specialist (Remote) Summary: Seeking a fluent French speaker to guide EU MDR project teams. Responsible for preparing and submitting EU MDR documentation for medical devices (Class , IIa, IIb, I sterile or reusable) for CE marking and EU commercial release. Collaborate with cross-functional teams and Notified Bodies. Supervision: Reports to Sr. Manager or Director of Regulatory Affairs. No supervisory responsibilities. Essential Duties: Ensure EU MDR compliance for

Regulatory Affairs Professional

Cygnus Professionals

Palo Alto, California, USA

Contract

Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches Product Registration Experience: Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical filesKnowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k)

Regulatory Affairs

Judge Group, Inc.

Palo Alto, California, USA

Full-time

Location: Palo Alto, CA Salary: $50.00 USD Hourly - $68.00 USD Hourly Description: Our client is currently seeking a Regulatory Affairs for a 12 month + contract. Hybrid position, 2 days in office (Palo Alto, CA). Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements * Identifies, analyzes and implements country specific requirements necessary for product related submis

IT Apps Specialist Sr

Randstad Digital

Remote or Cleveland, Ohio, USA

Contract

job summary: For this contractor assignment, as an IT Apps Specialist Sr on the External Communications team, you'll support key business initiatives to deliver solutions to our business partners. location: Cleveland, Ohio job type: Contract salary: $47 - 57 per hour work hours: 8am to 4pm education: Bachelors responsibilities: - Using RP for Rate Revisions (Auto/SL). - Accessibility in RP Studio. - Partner with stakeholders to define document requirements. - Use Oracle Documaker to cre

Senior Scheduling Specialist (Rail/Transit Projects) - 6 Years of Experience is Required

AECOM Corp. - Worldwide

Oakland, California, USA

Full-time

Company Description At AECOM, we're delivering a better world. We believe infrastructure creates opportunity for everyone. Whether it's improving your commute, keeping the lights on, providing access to clean water or transforming skylines, our work helps people and communities thrive. Our clients trust us to bring together the best people, ideas, technical expertise and digital solutions to our work in transportation, buildings, water, the environment and new energy. We're one global team -

Senior Sustainability Specialist

Fastly

San Francisco, California, USA

Full-time

Fastly helps people stay better connected with the things they love. Fastly's edge cloud platform enables customers to create great digital experiences quickly, securely, and reliably by processing, serving, and securing our customers' applications as close to their end-users as possible - at the edge of the Internet. The platform is designed to take advantage of the modern internet, to be programmable, and to support agile software development. Fastly's customers include many of the world's mos

Senior Environmental Sciences Specialist (NEPA) - Walnut Creek, CA

Black & Veatch

Walnut Creek, California, USA

Full-time

Together, we own our company, our future, and our shared success. As an employee-owned company, our people are Black & Veatch. We put them at the center of everything we do and empower them to grow, explore new possibilities and use their diverse talents and perspectives to solve humanity's biggest challenges in an ever-evolving world. With over 100 years of innovation in sustainable infrastructure and our expertise in engineering, procurement, consulting and construction, together we are build

Senior Technical Publication Specialist

Comrise

Fremont, California, USA

Contract

Senior Technical Publication Specialist - long term contract Opportunity with a leading Medical Device company As part of Sustaining R&D, the Lead Analyst, R&D Technical Writing is responsible for creating end-user regulatory complaint product labeling. The specialist contributes to new product development and design change (sustaining) activities in the areas of labeling design/release, technical writing, translation management, development of artwork/images and development or improvement of p

Lead Implementation Consultant

Sryven

Remote

Contract, Third Party

Position: Lead Implementation Consultant Location: Remote Estimated Start Work Date: June 1, 2024 May 31, 2025 Contract Period: Up to 12 months Experience Requirements: Software Development Lifecycle Experience:Minimum of seven (7) years of experience applying all activities required in the various software development lifecycle phases (Planning through Close-Out).Experience in data processing systems assessments, data classification, data governance, data models/design, data migration, data co

Senior Project Specialist

Mythics, LLC

Remote

Full-time

Job Overview & Responsibilities The Senior Project Specialist manages the delivery of customer facing Consulting projects of high dollar value, risk, and complexity, consistent with client requirements and procurement policies/procedures. Works under only very general direction, independently determine and develop approaches to solutions, handling complex assignments requiring considerable judgment and initiative. REMOTE opportunity. Responsibilities and Essential Duties: Lead and manage project

Sr. BI Specialist

Digitek Software, Inc.

Remote or Indianapolis, Indiana, USA

Contract, Third Party

One of our clients is looking for the position of Business Intelligence Sr. Specialist based on following skills: Location: Indiana Remote Expert level Tableau exp to provide technical assistance to BI analysts as well as quality improvement advice to the team leader. Must be proficient in project management and prioritization with the ability to succeed as an independent developer. Job responsibilities include, but are not limited to, the following: Promotes the utilization of technical servic

Senior Risk Adjustment Coding Specialist

Kforce Technology Staffing

Remote or Seattle, Washington, USA

Full-time

RESPONSIBILITIES: Kforce's Seattle, WA Healthcare Client is growing their Risk Adjustment team and are looking for a 100% remote Senior Risk Adjustment Coding Specialist. This role will be the lead/point person for the whole team. What's needed is ability to lead projects, and drive projects on their own. Not someone who needs to be given tasks or work each day. The role will be guiding other team members with the project work. Summary: Essentially, this is a coder/auditor role. The candidate w

Senior Business Intelligence (BI) Specialist

Swift Strategic Solutions Inc

Remote

Third Party, Contract

A Public Sector client of ours is looking for a Senior Business Intelligence (BI) Specialist to work on their ongoing project in the Indianapolis, IN office. Below are the additional details of this role: Required Skills: We need a minimum of 5+ years of hands-on experience in the following. Tableau, Power BI, SAS/R, Excel for data visualizationsSAS/R, Python, etc. for data cleaning and automationsDemonstrated experience with data manipulation, including cleansing, standardizing, and transformin

Senior Tableau Server Specialist

GLOBAL VISSE INC

Remote

Contract

Business Intelligence (BI) Senior Specialist /Tableau server Specialist 12+ Months Contract Expert level Tableau exp to provide technical assistance to BI analysts as well as quality improvement advice to the team leader. Must be proficient in project management and prioritization with the ability to succeed as an independent developer.Job responsibilities include, but are not limited to, the following: Promotes the utilization of technical services to resolve business issues within the enterpr

Sr BI Specialist-Indiana (w2/1099)

Silver Xis, Inc.

Remote

Full-time

Business Intelligence (BI) Senior Specialist (737507) 06/03/2024 to 05/31/2025 Remote Webcam only Indianapolis, IN 46204 Expert level Tableau exp to provide technical assistance to BI analysts as well as quality improvement advice to the team leader. Must be proficient in project management and prioritization with the ability to succeed as an independent developer. **Local Candidates Only ** Manager confirmed there will be no software development. There will be Tableau server maintenance Job

Business Intelligence (BI) Senior Specialist

Scadea Solutions Inc

Remote

Contract

Role: Business Intelligence (BI) Senior Specialist Location: Remote Duration:6+months Expert level Tableau exp to provide technical assistance to BI analysts as well as quality improvement advice to the team leader. Must be proficient in project management and prioritization with the ability to succeed as an independent developer. Job responsibilities include, but are not limited to, the following: Promotes the utilization of technical services to resolve business issues within the enterprise,

Senior REDCap Configuration Specialist

Delphi-US

Remote

Contract

Title: Senior REDCap Configuration Specialist (Contract)- Job#4986Location: Remote Job Description: Our client located in the Providence, RI has an immediate opening for a Senior REDCap Configuration Specialist to join their team in a remote capacity. The Senior REDCap Configuration Specialist will work closely with epidemiologists and IT staff. The specialist will focus on Application Development leveraging the REDCap platform. The initial focus will be on developing an Outbreak Management Sy