Regulatory Affairs Manager jobs in Minneapolis, MN

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Senior Regulatory Affairs Specialist
  • ICONMA, LLC
  • Saint Paul, MN FULL_TIME

  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.

    Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

    Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.

    Identify opportunity for regulatory affair processes and drive changes to completion.

    Perform assigned regulatory activities including submissions/responses to country authorities.

    Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.

    Assist in strategy implementation and operations for regulatory affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.

    Assist in maintaining Regulatory records and files.

    Review product changes as assigned and assess required EU MDR submissions/notifications.



    Requirements

    Have working knowledge in EU MDR.

    Have working knowledge in Regulatory Change Assessment.

    Have working knowledge in US and EU medical device submissions.

    Have experience supporting internal and external inspections.

    Work cross-functionally and in a matrixed environment.

    Have experience with continuous improvement activities.

    BA Degree Required.

    3-5 years experiences in Medical Device Regulatory Affairs.

    Strong oral communication and interpersonal skills.

    Proficient in technical writing.

    Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.

    MS Office Suite including an Intermediate level with Excel using Pivot Tables, Creating Trackers in Excel and Monitoring these/Conditional Formatting.



    As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

  • 18 Days Ago

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Sr. Regulatory Affairs Specialist
  • Medtronic
  • Minneapolis, MN FULL_TIME
  • Position Description: Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and internat...
  • 3 Days Ago

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Regulatory Affairs Specialist
  • PMT Corporation
  • Chanhassen, MN FULL_TIME
  • Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference.PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products...
  • 7 Days Ago

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Regulatory Affairs Analyst II
  • Danaher
  • Chaska, MN FULL_TIME
  • Wondering what’s within Beckman Coulter? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and...
  • 10 Days Ago

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Regulatory Affairs Specialist II
  • Laborie Medical Technologies Corp
  • Minnetonka, MN FULL_TIME
  • We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready...
  • 14 Days Ago

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Regulatory Affairs Specialist
  • St. Croix Hospice
  • OAKDALE, MN OTHER
  • Job Details Job Location: Administration - OAKDALE, MN Position Type: Full Time Salary Range: Undisclosed DescriptionThe Regulatory Affairs Specialist is responsible for assisting the St. Croix Hospic...
  • 16 Days Ago

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0 Regulatory Affairs Manager jobs found in Minneapolis, MN area

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Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC
  • Boston Scientific
  • Saint Paul, MN
  • Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: Th...
  • 4/26/2024 12:00:00 AM

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Metrics Specialist - REMOTE
  • Net Health
  • Minneapolis, MN
  • About Net Health Belong. Thrive. Make a Difference. Are you looking for a meaningful and satisfying career where you hav...
  • 4/26/2024 12:00:00 AM

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Health Operations Data Analyst (NOT REMOTE)
  • Watts Healthcare Corporation
  • Minneapolis, MN
  • With over 50 years of service, our goal is to improve the health of the community we serve by creating easier access to ...
  • 4/25/2024 12:00:00 AM

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Senior Manager, Regulatory Affairs - Cell Therapies (Remote-based)
  • Fresenius Kabi Usa Llc
  • Minneapolis, MN
  • Job Summary The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help de...
  • 4/23/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Custom Search, Inc.
  • Minnetonka, MN
  • Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance w...
  • 4/22/2024 12:00:00 AM

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Senior Manager Regulatory Affairs
  • Barrington James
  • Saint Paul, MN
  • Senior Manager Regulatory Affairs - (Medical Device) - Hybrid in MNOur client is an, looking for a Senior Manager Regula...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs & Quality Compliance Specialist
  • Steris Corporation
  • Eden Prairie, MN
  • At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science ...
  • 4/22/2024 12:00:00 AM

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Budget & Evaluation Analyst
  • City of Minneapolis, MN
  • Minneapolis, MN
  • Salary: $85,550.40 - $100,097.92 Annually Location : Minneapolis, MN Job Type: Full-time Remote Employment: Flexible/Hyb...
  • 4/22/2024 12:00:00 AM

Minneapolis (/ˌmɪniˈæpəlɪs/ (listen)) is the county seat of Hennepin County and the larger of the Twin Cities, the 16th-largest metropolitan area in the United States. As of 2017, Minneapolis is the largest city in the state of Minnesota and 45th-largest in the United States, with an estimated population of 422,331. The Twin Cities metropolitan area consists of Minneapolis, its neighbor Saint Paul, and suburbs which altogether contain about 3.6 million people, and is the third-largest economic center in the Midwest. Minneapolis lies on both banks of the Mississippi River, just north of the riv...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$146,163 to $206,170
Minneapolis, Minnesota area prices
were up 1.4% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020