Top Regulatory Affairs Executive jobs in Minneapolis, MN

Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (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.

  • 17 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...
  • 2 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...
  • 6 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...
  • 9 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...
  • 13 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...
  • 15 Days Ago

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0 Top Regulatory Affairs Executive jobs found in Minneapolis, MN area

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Regulatory Affairs Specialist
  • Insight Global
  • Saint Paul, MN
  • Insight Global is seeking a Regulatory Affairs Specialist to join one of our largest chemical and water clients in Minne...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Specialist II - Electrophysiology
  • Abbott
  • Minneapolis, MN
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 4/26/2024 12:00:00 AM

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Sr Regulatory Affairs Specialist -Peripheral Vascular Health (remote)
  • Medtronic
  • Minneapolis, MN
  • Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to th...
  • 4/24/2024 12:00:00 AM

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Principal Regulatory Affairs Specialist
  • Philips
  • Minneapolis, MN
  • Philips Principal Regulatory Affairs Specialist Plymouth , Minnesota Apply Now Principal Regulatory Affairs Specialist- ...
  • 4/23/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Insight Global
  • Saint Paul, MN
  • Location: St. Paul, MN - remote to start, but will transition to a hybrid model in the coming months Contract: 12 month ...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • PMT Corporation
  • Chanhassen, MN
  • Find Fulfillment in Work Every Day! We Offer Careers that Make a Difference. PMT Corporation, located in Chanhassen, Min...
  • 4/22/2024 12:00:00 AM

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Advanced Regulatory Affairs Specialist
  • Bio-Techne
  • Minneapolis, MN
  • **By joining the Bio-Techne team, you will have an impact on future cutting-edge research. Bio-Techne andall ofits brand...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Specialist II - Electrophysiology
  • Abbott Laboratories
  • Plymouth, MN
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 2/22/2024 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 Top Regulatory Affairs Executive jobs
$310,787 to $508,456
Minneapolis, Minnesota area prices
were up 1.4% from a year ago

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