Regulatory Affairs Manager jobs in Eden Prairie, 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.

  • 22 Days Ago

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Regulatory Affairs Specialist
  • Encore Medical, Inc.
  • Saint Paul, MN FULL_TIME
  • Company Description Encore-Medical Inc., a device manufacturer of products used in the structural heart market segment. Our Patent Foramen Ovale (PFO) and Atrial Septal Defect (ASD) occlusive technolo...
  • 2 Days Ago

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Regulatory Affairs Specialist I
  • DiaSorin
  • Stillwater, MN FULL_TIME
  • Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 yea...
  • 3 Days Ago

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Regulatory Affairs Specialist I
  • DiaSorin
  • Stillwater, MN FULL_TIME
  • Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 yea...
  • 3 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...
  • 7 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...
  • 11 Days Ago

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0 Regulatory Affairs Manager jobs found in Eden Prairie, MN area

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Regulatory Affairs Manager
  • Custom Search Inc.
  • Osseo, MN
  • Our Twin City client is creating a novel approach to addresses the challenges of Type 2 diabetes. Their procedure applie...
  • 4/29/2024 12:00:00 AM

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Principal Regulatory Affairs Strategist
  • Canon Medical Informatics
  • Hopkins, MN
  • POSITION OVERVIEW We are looking for a talented Principal Regulatory Affairs Strategist to join our team at Canon Medica...
  • 4/29/2024 12:00:00 AM

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Senior Regulatory Affairs Associate
  • Elucent Medical, Inc.
  • Eden Prairie, MN
  • Job Title: Senior Regulatory Affairs Associate Reports to: Vice President – RA and QA EDUCATION, BUSINESS EXPERIENCE AND...
  • 4/28/2024 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...
  • 4/27/2024 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 ...
  • 4/27/2024 12:00:00 AM

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Senior Principal Reporting & Analytics Leader
  • Tennant Company
  • Eden Prairie, MN
  • With more than $1B in revenue, Tennant Company is a globally recognized leader in the cleaning equipment industry. For t...
  • 4/27/2024 12:00:00 AM

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Senior VP of Senior Living Operations
  • HDG
  • Hopkins, MN
  • Our mission is to make people's lives better by providing quality care, service, and consulting We believe that our resi...
  • 4/26/2024 12:00:00 AM

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Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Minneapolis, MN
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

Eden Prairie is an edge city 12 miles (19 km) southwest of downtown Minneapolis in Hennepin County, and the 12th-largest city in the State of Minnesota. It is the 7th-largest suburb in the Twin Cities, with a population of 60,797 at the 2010 census. The city is on the north bank of the Minnesota River, upstream from its confluence with the Mississippi River. Eden Prairie is an affluent suburb with a mixed-income city model. It is home to 7,213 firms, municipal and regional parks, conservation areas, trails, and recreational facilities. There are walking trails around Purgatory Creek and Starin...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$146,262 to $206,308
Eden Prairie, 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