Regulatory Affairs Director jobs in Minneapolis, MN

Regulatory Affairs Director oversees regulatory matters and executes the 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 Regulatory Affairs Director 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, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (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.

  • 16 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...
  • 1 Day 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...
  • 5 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...
  • 8 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...
  • 12 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...
  • 14 Days Ago

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0 Regulatory Affairs Director jobs found in Minneapolis, MN area

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REMOTE: Medical Director, Utilization Management and Medical Policy
  • Evry Health
  • Minneapolis, MN
  • About the Role Evry Health is hiring a tech-savvy Medical Director to lead medical policy and utilization management. As...
  • 4/24/2024 12:00:00 AM

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Senior Director, Regulatory Affairs - REMOTE
  • Proclinical Staffing
  • Minneapolis, MN
  • Senior Director, Regulatory Affairs - Permanent - Remote Proclinical Staffing is seeking a Senior Director, Regulatory A...
  • 4/23/2024 12:00:00 AM

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*Remote* - Drug Product, MSAT - Principal/ Associate Director
  • Northreach
  • Minneapolis, MN
  • Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Ou...
  • 4/23/2024 12:00:00 AM

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Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – RETAINED SEARCH
  • Cornerstone Search Group
  • Minneapolis, MN
  • Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained Search Summary:...
  • 4/23/2024 12:00:00 AM

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Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – RETAINED SEARCH
  • Cornerstone Search Group
  • Minneapolis, MN
  • Head, Corporate & Legal Affairs – Strategic Advisor Reporting to CEO; Innovative CRO – Remote – Retained Search Summary:...
  • 4/23/2024 12:00:00 AM

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Senior Director, Clinical Biomarkers - REMOTE
  • Proclinical Staffing
  • Minneapolis, MN
  • Senior Director, Clinical Biomarkers - Permanent - Remote Proclinical Staffing is seeking a Senior Director, Clinical Bi...
  • 4/22/2024 12:00:00 AM

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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...
  • 4/21/2024 12:00:00 AM

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*Remote* - Drug Product, MSAT - Principal/ Associate Director
  • Northreach
  • Minneapolis, MN
  • Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Ou...
  • 4/20/2024 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 Director jobs
$179,337 to $255,417
Minneapolis, Minnesota area prices
were up 1.4% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020