Regulatory Affairs Specialist Jobs in Minneapolis, MN

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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.

CMC 2 Regulatory affairs Specialist

Dizer Corp

Remote

Contract, Third Party

Job Title: CMC 2 Regulatory affairs Specialist Location: Remote Description: Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment

Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLC

Remote

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for a remote based opportunity to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents. Support document workf

Regulatory Affairs Manager - Electrophysiology

Abbott Laboratories

Plymouth, Minnesota, USA

Full-time

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 spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo

Regulatory Affairs Manager - Structural Heart (on-site)

Abbott Laboratories

Saint Paul, Minnesota, USA

Full-time

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 spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future

Department Specialist III

Pyramid Consulting, Inc.

Plymouth, Minnesota, USA

Contract

Immediate need for a talented Department Specialist . This is a 05+ months Contract opportunity with long-term potential and is located in Plymouth, MN(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 24-18508 Pay Range: $28 - $32/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Greet and welcome guests.Ans

Desktop Support Specialist

LaSalle Network

Woodbury, Minnesota, USA

Full-time

LaSalle Network is currently partnered with one of our clients, a home care agency committed to enhancing the quality of life for their clients, to find additional help desk support. They are currently seeking a Desktop Support Specialist to join their team onsite in Woodbury, Minnesota. Desktop Support Specialist Responsibilities: Install and upgrade Operating Systems and Computer software Handle all the procurement/forecast related activities for all desktop/laptops and printers Maintain the d

Senior IT Service Desk Specialist

Randstad Digital

Minneapolis, Minnesota, USA

Full-time

job summary: How Will You Make a Difference? Answer IT Service Desk calls and emails, providing solutions and/or escalating requests and problems to designated second level responders. Act as a point of escalation and support for other members of the Service Desk for advanced technical issues and requests. Complete tickets for IT Service Desk inquiries and follow-ups to ensure tickets are updated and acknowledged to the point of verifying completion and closing them out. Monitor and process the

Provisioning Specialist

U.S. Bank

Hopkins, Minnesota, USA

Full-time

At U.S. Bank, we're on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and succeed. We believe it takes all of us to bring our shared ambition to life, and each person is unique in their potential. A career with U.S. Bank gives you a wide, ever-growing range of opportunities to discover what makes you thrive at every stage of your career. Try new things, learn new skills and di

Human Resources Specialist 3

First Tek, Inc.

Remote

Full-time

My name is Gaurav and I'm a Technical Recruiter at First Tek. We are currently sourcing for candidates with the following skills. Kindly forward your resume if interested, do share with your friends and colleagues as well. Job Title: Human Resources Specialist 3 Location: Portland, OR-Remote Client: Bonneville Power Administration Duration: 12+ months Rate: $72/hr. on W2 Job Id: BPAJP00011249 Number of Days Onsite per Week: Remote REQUIREMENTS: Education & Corresponding Experience (required on

Power BI Specialist Part-time

Randstad Digital

Remote or Durham, North Carolina, USA

Contract

job summary: We are looking for a part-time Power BI resource to help us with some integration work on an on-going basis. This role is approximately 5-10 hours per week and involves integrating Power BI with Zen QS and Cherwell. Will also involve modications and enhancements to dashboards. We are looking for someone with 5+ years creating and modifying Power BI dashboard and experience integrating Power BI with other tools. Flexible work hours and 100% remote. location: DURHAM, North Carolina

Marketing Automation Specialist

Randstad Digital

Remote or Madison, Wisconsin, USA

Contract

job summary: Our client is looking for an out-of-the-box and entreprenurial thinker to join their team as a Marketing Automation Specialist. This position is responsible for consulting, developing, implementing and optimizing digital touch points essential in executing on our customer experience strategy. This role will make business objectives and strategies a reality by developing and delivering the technology solutions through Marketing Cloud, Salesforce or other digital platforms. The ideal

CDI Specialist

SSI People

Remote

Contract

CDI Specialist Clinical Documentation Improvement (CDI) services provide a unique niche within our healthcare team that crosses between financial & clinical services.The main goal of the program is to ensure that billing and coding practices are compliant and accurate, reducing the risk of claim denials and improving financial performance.Assist with managing external vendor(s).Certifications needed: CCS IP Certified Coding SpecialistCCDS Certified Coding Documentation Specialist5 10 years of ex

Web Support Specialist - Fully Remote

Randstad Digital

Remote or Owings Mills, Maryland, USA

Full-time

job summary: Description: This position responds to calls, emails, or online chat regarding website/sitelet troubleshooting, site updates, plugin updates, server or hosting issues, etc. Assist with identifying the root cause of problems; manages and resolves issues in a constantly changing environment. Responsibilities Provide technical support to customers via email, phone and video. Manage and resolve incoming martech support requests through our ticketing system Build and update individua

Alogent Support Specialist

Cyma Systems Inc

Remote

Contract, Third Party

Job Title: Alogent Support Specialist Job Type: 12+ Contract Location: Onsite @ Cincinnati, OH. Skills: Alogent, MSSQL Job Description Having 8+ years of implementation/development/support experience on alogent Products like Alogent interactive capture(AIC) , Alogent Payment Gateway(APG), Alogent Warehouse (AWARE) Microsoft SQL Server databases.working knowledge of scanners and interaction of alogent ProductsSupporting integrations with SOAP and RESTful web servicesDocument Recognition software

Oracle ERP Integration Specialist / Oracle EBS Integration Specialist

Svam International, Inc.

Remote

Third Party, Contract

Oracle ERP Integration Specialist / Oracle EBS Integration Specialist remote with travel on need basis to Long Island City NY For travel the hotel and flight expenses will be taken care of by the client Job Overview Oracle ERP Integration Specialist / Oracle EBS Integration Specialist Duration: 05/2024 07/2025 Good Functional knowledge of Oracle Cloud Financials Modules (GL/AR/AP/CM/FA/Procurement/Projects/Grants/Basic HCM)Experience in independently driving user requirements & process workshops

Mainframe ACF2 Security Specialist

Randstad Digital

Remote or Bethesda, Maryland, USA

Contract

job summary: Randstad Federal is seeking a Mainframe ACF2 Security Specialist in support of a program with Department of Treasury location: BETHESDA, Maryland job type: Contract salary: $80 - 90 per hour work hours: 8am to 4pm education: Bachelors responsibilities: Overview: In this role, the individual will be responsible for the administration of user access and the privileges to applications and systems, ensuring that access requests are properly authorized, appropriately documented, an