Top Regulatory Affairs Executive jobs in Minnesota

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.

  • 18 Days Ago

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Regulatory Affairs Specialist
  • USA 3M Company
  • Minnesota, MN FULL_TIME
  • Job Description: Regulatory Affairs Specialist Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life...
  • 22 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
  • Medtronic
  • Rice, MN FULL_TIME
  • Careers that Change Lives Medtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimul...
  • 11 Days Ago

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Regulatory Affairs Expert
  • Prokatchers
  • Saint Louis, MO
  • Job Description: With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tas...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Lake Forest, IL
  • Regulatory Affairs Specialist – Onsite in Lake Forest, IL Must be able to work W2 Summary Our client, a Fortune-500 Medi...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • ProKatchers LLC
  • St Louis, MO
  • Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
  • 4/25/2024 12:00:00 AM

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Regulatory Affairs Expert
  • Integrated Resources, Inc ( IRI )
  • St Louis, MO
  • Job Title: Regulatory Affairs Expert Job Location: St. Louis, MO- Hybrid Job Duration: 12 Months- Temp to perm possibili...
  • 4/25/2024 12:00:00 AM

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Regulatory Affairs Expert
  • ProKatchers
  • St. Louis, MO
  • Job Description: · With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory t...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Expert
  • Integrated Resources Inc ( Iri )
  • Saint Louis, MO
  • Job Title: Regulatory Affairs Expert Job Location: St. Louis, MO- Hybrid Job Duration: 12 Months- Temp to perm possibili...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Prokatchers Llc
  • Saint Louis, MO
  • Job Title: Regulatory Affairs Specialist Location: 63103, St Louis, Missouri, United States Duration: 24 Months Job Desc...
  • 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

Minnesota (/ˌmɪnɪˈsoʊtə/ (listen)) is a state in the Upper Midwest and northern regions of the United States. Minnesota was admitted as the 32nd U.S. state on May 11, 1858, created from the eastern half of the Minnesota Territory. The state has a large number of lakes, and is known by the slogan the "Land of 10,000 Lakes". Its official motto is L'Étoile du Nord (French: Star of the North). Minnesota is the 12th largest in area and the 22nd most populous of the U.S. states; nearly 60% of its residents live in the Minneapolis–Saint Paul metropolitan area (known as the "Twin Cities"). This area i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$299,656 to $490,245

Top Regulatory Affairs Executive in Wilmington, NC
On average, a Doctorate Degree is the highest level of education for a Top Regulatory Affairs Executive.
February 04, 2020
Top Regulatory Affairs Executive in Champaign, IL
If you were hiring a person for this job As Top Regulatory Affairs Executive, what would you look for.
February 06, 2020
Top Regulatory Affairs Executive in Boca Raton, FL
During the interview As Top Regulatory Affairs Executive process employers will want to find out how you respond to supervision.
February 21, 2020