Regulatory Affairs Director jobs in La Crosse, WI

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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Regulatory Affairs Spec I
  • Benchmark Electronics, Inc
  • Winona, MN FULL_TIME
  • Benchmark provides comprehensive solutions across the entire product lifecycle; leading through its innovative technology and engineering design services, leveraging its optimized global supply chain, and delivering world-class manufacturing services. The industries we serve include: commercial aerospace, defense, advanced computing, next generation telecommunications, complex industrials, medical, and semiconductor capital equipment.

    Summary:
    Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment. Provides regulatory and quality systems support for manufacturing, operations and product development.

    Responsibilities:
    • Participates and contributes to regulatory departmental management meetings and goal accomplishment
    • Serves as customer team liaison for customer audits/questions related to specification requirements
    • Works directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication
    • Monitors and report on key quality and performance indicators as related to regulatory system conformance
    • Keeps updated on latest and future regulatory requirements and quality management standards, incorporating changes and additions into review and audit practices
    • Actively participates in continuous improvement initiatives
    • Reviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance to requirements
    • Participates with customer teams, supporting NPI and ongoing production needs related to regulatory requirements
    Other information:
    • Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
    • Capable of performing timely and accurate review of MRR and MRR waiver submittal
    • Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
    • Demonstrate effective customer interface skills
    • Demonstrate confidentiality
    • Ability to work with supervision and guidance
    • Demonstrate strong and effective interpersonal skills
    • Demonstrate strong presentation and communication skills, both written and verbal, with internal and external customers
    • Demonstrate strong problem solving and decision making skills
    • Demonstrate strong organizational skills
    • Knowledge of ISO quality management standards and other standards related to business sectors that support customers’ needs/products; electronic device contract manufacturing preferred
    • 4 year College Degree or equivalent combination of education and experience as approved by executive management
    • 0-2 years of basic regulatory experience

    Education:

    Geographical Location: Minnesota:Winona

    Physical Location: Winona, MN - Central (4155)

    Shift: Shift 1

    Work Schedule: M-F 0800-1630

    Full Time


    Benchmark is an equal opportunity employer. We are bringing together a diverse workforce with unique talents, life experiences, cultures, and perspectives to promote an innovative, collaborative, and creative place to work. If you need assistance or an accommodation due to a disability, please email us at careers@bench.com .

  • 28 Days Ago

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Student Affairs Program Specialist
  • University of Wisconsin System
  • Eau Claire, WI FULL_TIME
  • POSITION: Two full-time Coordinators of Student Activities positions are available in the Activities, Involvement, and Leadership Office beginning May 2024. The working title for this assignment is Co...
  • 10 Days Ago

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Covid System Administrator - US Department of Veteran Affairs
  • TLN Worldwide Enterprises Inc
  • Tomah, WI FULL_TIME
  • DescriptionPosition Title: COVID Systems AdministratorAs an onsite Systems Administrator on our project, you will be supporting the Department of Veterans' Affairs. You'll analyze problem areas and op...
  • 22 Days Ago

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Activity Director / Director of Celebrations
  • Oaks Gardens Place
  • Altoona, WI FULL_TIME
  • LakeHouse Senior Living proudly operates 36, care- and lifestyle-focused Active Independent Living, Assisted Living, Memory Care, and available, short-term Respite Care communities located throughout ...
  • 1 Month Ago

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Director of Finance
  • H&S Manufacturing Co Inc
  • Marshfield, WI FULL_TIME
  • Summary:Directs financial activities of H & S Manufacturing Company Inc. financial organization. Prepares or directs the preparation of reports which summarize and forecast company business activity a...
  • 7 Days Ago

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Center Director
  • Tiny Tree Academy
  • Chippewa Falls, WI CONTRACTOR,FULL_TIME
  • Tiny Tree Academy of Chippewa Falls is looking to find an organized, positive and upbeat leader to join our Tiny Tree family. Being the center director is a high-paced career that also requires a stro...
  • 9 Days Ago

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0 Regulatory Affairs Director jobs found in La Crosse, WI area

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Environmental Health and Safety Manager - The Toro Company
  • The Toro Company
  • Tomah, WI
  • Job Purpose: The Environmental, Health and Safety (EHS) Manager is responsible for providing daily direction, developing...
  • 4/15/2024 12:00:00 AM

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Associate Executive Director
  • Careerbuilder
  • La Crosse, WI
  • Enter your email to create a Candidate Profile and proceed with next steps Email If you are a California resident, pleas...
  • 4/15/2024 12:00:00 AM

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Food Retail Brand Location Supervisor - Viterbo University
  • Aramark
  • La Crosse, WI
  • Job Description The Food Retail and Brand Location Supervisor is responsible for the supervision, training, and manageme...
  • 4/14/2024 12:00:00 AM

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General Manager II - Store 6311
  • Advanceautoparts
  • La Crosse, WI
  • Location: Location: General Manager II - Store 6311 in La Crosse, WI at Advance Auto Parts **Location:** **Career Descri...
  • 4/14/2024 12:00:00 AM

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Human Services Fiscal Manager
  • La Crosse County, WI
  • La Crosse, WI
  • Salary: Depends on Qualifications Location : La Crosse, WI Job Type: Full Time Department: Human Services Division: Huma...
  • 4/13/2024 12:00:00 AM

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Technical Director
  • AEG
  • La Crosse, WI
  • Position: Technical Director, VirtCh Location: La Crosse, Wisconsin Position Description and Expectations: As a Senior T...
  • 4/13/2024 12:00:00 AM

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Assistant General Manager
  • Panera Bread Company
  • Onalaska, WI
  • **Assistant General Manager** Location 1230 Crossing Meadow Drive, Onalaska, WI 54650, United States of America Category...
  • 4/12/2024 12:00:00 AM

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Pet Grooming Salon Manager
  • PetSmart
  • Onalaska, WI
  • PET GROOMING SALON MANAGER We value your experience and are currently offering a $2000 sign-on bonus OR a $1500 sign-on ...
  • 12/29/2017 12:00:00 AM

La Crosse is located on the western border of the midsection of Wisconsin, on a broad alluvial plain along the east side of the Mississippi River. The Black River empties into the Mississippi north of the city, and the La Crosse River flows into the Mississippi just north of the downtown area. Just upriver from its mouth, this river broadens into a marshland that splits the city into two distinct sections, north and south. According to the United States Census Bureau, the city has a total area of 22.54 square miles (58.38 km2), of which, 20.52 square miles (53.15 km2) is land and 2.02 square m...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$159,054 to $226,529
La Crosse, Wisconsin area prices
were up 1.3% 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