Regulatory Affairs Specialist jobs in Wisconsin

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Sr. Regulatory Affairs Specialist
  • Oterra
  • Sturtevant, WI FULL_TIME
  • Job Description:

    Sr. Regulatory Affairs Specialist is responsible for ensuring compliance with all regulatory requirements within the US & Canada for colors in food & beverage, pet food, nutraceuticals and biotechnology. This role involves monitoring regulations, creating and maintaining compliance conformity documents, advising internal and external stakeholders, and supporting customers with labelling guidance. Works independently to provide customers with product regulatory information in accordance with US FDA/USDA/Health Canada regulations, customer specific guidelines and international regulations. This role reports into Head of Application, NA and has a hybrid-remote work schedule based out of Mount Pleasant, WI.

    What will be your key responsibilities?

    • Ensure the compliance of all products sold in the US and Canada
    • Track, monitor and communicate all current, proposed, and new regulations that may impact the company.
    • Actively participate in relevant trade associations (NATCOL) to stay updated on industry trends and regulatory developments.
    • Researches and prepares timely and accurate responses to customer inquiries regarding the domestic and international regulatory status of products, specification, allergen, labelling, GMO, Organic and other certifications.
    • Assists in the operation of systems and procedures to ensure timely and accurate data collection, maintenance and delivery of consistent regulatory information throughout the organization.
    • Monitors regulatory changes affecting company products and communicates to appropriate inter-company stakeholders.
    • Supports the business unit division regarding securing registrations, certifications and regulatory dossiers for internal use and submission to government and 3rd party entities.
    • Train internal business teams about regulatory topics and updates
    • Liaise with Authorities (FDA, USDA, Health Canada, etc.), consultants and local associations.
    • Supports the sales team with assisting customers on ingredient regulation and labeling requirements.
    • Work closely with R&D, QA, QC, Production, Sales & Marketing

    What are we looking for?

    Minimum Requirements

    • Bachelor’s degree in nutrition, biochemistry, food science, food safety, food process engineering or related field
    • 7-10 years experience in regulatory compliance at a B2B food and beverage company is required with significant expertise in ingredient compliance, product compliance, claims, labelling
    • Systems and data management experience- SAP, Salesforce, data analytics software, product lifecycle management tools
    • Expertise in food and beverage categories; beverage, bakery, confectionery, dairy, & petfood

    Preferred Qualifications

    • MS degree in nutrition, biochemistry, food science, food safety, food process engineering or related field and additional training course work in regulatory science

    International regulatory experience

    Further information and application

    We would love to know more about you and your motivation for this job! Please send us a CV in English, latest 60 days from day of posting. If you have any questions regarding the position, please contact hiring manager Chari Rai at chari.rai@oterra.com.

    Please note that we will be working with a continuous selection process, which means that we may close the application process earlier than stated if we find the right candidates. So, don’t delay, please send us your application today.

    Start Date: As soon as possible, with regards of the notice period.
  • 1 Day Ago

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Regulatory Affairs Specialist
  • Real Staffing
  • Kenosha, WI FULL_TIME
  • We have a current opportunity for a Regulatory Affairs Specialist on a 6 Month Contract to hire. The position will be based in Kenosha and candidates will be converted to perm after 6 months. Desired ...
  • 2 Days Ago

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Regulatory Affairs Specialist
  • Kelly
  • Beloit, WI FULL_TIME
  • This job offer is not available in your country. Kelly is seeking qualified candidates for a Regulatory Affairs Specialist to work at one of top clients in Beloit, WI. Pay : $30 / hr - $40 / hr depend...
  • 8 Days Ago

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Regulatory Affairs Specialist (m/w/d)
  • medmix
  • Kiel, WI FULL_TIME
  • UnternehmensbeschreibungAls Teil des Dental Segments der medmix AG produziert und vertreibt die medmix Deutschland GmbH international Medizinprodukte an die Dentalindustrie und den Dentalhandel. Rund ...
  • 20 Days Ago

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Regulatory Affairs Analyst
  • American Orthodontics
  • Sheboygan, WI FULL_TIME
  • Job DetailsDescriptionDuties and ResponsibilitiesCreate, manage, and organize technical documentation in a document control systemCommunicate with customers and regulatory agencies to support product ...
  • 1 Day Ago

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Regulatory Affairs Engineer
  • American Orthodontics
  • Sheboygan, WI FULL_TIME
  • Job DetailsDescriptionDuties and ResponsibilitiesSupport Engineering and Product Development teams to successfully complete and obtain product registrationsDetermine the types of regulatory submission...
  • 1 Day Ago

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Regulatory Affairs Specialist
  • Net2Source Inc.
  • Palo Alto, CA
  • Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
  • 6/2/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Santa Clara, CA
  • Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory aff...
  • 6/2/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Alphatec Spine
  • Carlsbad, CA
  • Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
  • 6/1/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Santa Clara, CA
  • Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
  • 6/1/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 5/31/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Astrix
  • Fort Worth, TX
  • Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
  • 5/31/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Highridge Medical
  • Westminster, CO
  • Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
  • 5/30/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • CM Medical Recruitment
  • CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
  • 5/29/2024 12:00:00 AM

Wisconsin is bordered by the Montreal River; Lake Superior and Michigan to the north; by Lake Michigan to the east; by Illinois to the south; and by Iowa to the southwest and Minnesota to the northwest. A border dispute with Michigan was settled by two cases, both Wisconsin v. Michigan, in 1934 and 1935. The state's boundaries include the Mississippi River and St. Croix River in the west, and the Menominee River in the northeast. With its location between the Great Lakes and the Mississippi River, Wisconsin is home to a wide variety of geographical features. The state is divided into five dist...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$75,429 to $101,083

Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019