Regulatory Affairs Manager jobs in Fort Worth, TX

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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Global Regulatory Affairs Manager II
  • YOH Services LLC
  • Fort Worth, TX FULL_TIME
  • Global Regulatory Affairs Manager II

    Category: Life Science

    Employment Type: Contract

    Reference: BH-371432

    Global Regulatory Affairs Manager II - Fort Worth
    9 month contract
    W2 Pay Rate: $55.00 - $59.28/hr

    Position Overview

    This position will independently provide tactical and strategic leadership on complex EU MDR projects within the Global Regulatory Affairs organization by actively compiling and authoring EU MDR-compliant STeD files.


    Main Areas of Responsibilities

    Independently lead development, remediation, planning, and authoring of EU MDR STeD files for Class IIa and IIb products.
    Coordinate and lead cross-functional teams aimed at remediating MDD STeD files into MDR-compliant files, including Manufacturing, R&D, Pre-Clinical Safety, and Quality.
    Lead project review meetings for management's oversight on progress and risks.


    Requirements

    Experience in a medical devices required.
    Experience in MDR STeD file authoring required.
    Develop and implement regulatory strategy aligned with business strategy.
    Excellent communication and project management skills.


    Preferred Skills/Qualification

    Strong technical writing skills.
    Strong project management skills.
    B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience
    MS degree and 3 years of regulatory experience.
    PhD and 1 years of regulatory experience.

    Opportunity is Calling, Apply Now!

    What's In It For You?
    We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

    • Medical, Dental & Vision Benefits
    • 401K Retirement Saving Plan
    • Life & Disability Insurance
    • Direct Deposit & weekly ePayroll
    • Employee Discount Programs
    • Referral Bonus Programs
    Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

    Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

    Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    Visit to contact us if you are an individual with a disability and require accommodation in the application process.



    Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

     

  • 3 Days Ago

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Global Regulatory Affairs Manager II - Contract
  • TalentBurst, Inc.
  • Fort Worth, TX FULL_TIME
  • Position: Global Regulatory Affairs Manager II, Req#: 2438-1Location: Houston, TX (100% Remote)Duration: 9 Months Contract Job Description: This position will independently provide tactical and strate...
  • 5 Days Ago

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Regulatory Affairs Specialist II
  • YOH Services LLC
  • Fort Worth, TX FULL_TIME
  • Regulatory Affairs Specialist II Category: Regulatory Employment Type: Contract Reference: BH-371059 Regulatory Affairs Specialist II needed for a one year W2 contract for a Global Life Science compan...
  • 14 Days Ago

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Regulatory Affairs Specialist
  • Sally Beauty Holdings, Inc.
  • Denton, TX FULL_TIME
  • Review labels of private label products for regulatory compliance in the US and applicable international markets. Review list of ingredients for accuracy, and inclusion of all required use instruction...
  • 8 Days Ago

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Regulatory Affairs Specialist II - Temporary
  • Bio-Rad Laboratories
  • Fort Worth, TX TEMPORARY
  • Provide regulatory support for Bio-Rad products that will be transitioning from the IVDD to IVDR CE Marking. Collaborate with cross-functional groups (e.g., Quality Assurance, Research & Development, ...
  • 14 Days Ago

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Global Regulatory Affairs Principal Specialist
  • Alcon
  • Fort Worth, TX FULL_TIME
  • Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position: Alcon is looking to hire a Global Regulatory Affairs Princi...
  • 1 Month Ago

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0 Regulatory Affairs Manager jobs found in Fort Worth, TX area

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Biostatistician Consultant - 6 months remote
  • Planet Technology
  • Fort Worth, TX
  • REMOTE EST 6 month contract open to extension and perm hire Join a team as a Biostatistician - act as an independent pro...
  • 3/19/2024 12:00:00 AM

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Biostatistician Consultant - 6 months remote
  • Planet Technology
  • Dallas, TX
  • REMOTE EST 6 month contract open to extension and perm hire Join a team as a Biostatistician - act as an independent pro...
  • 3/19/2024 12:00:00 AM

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Biostatistician Consultant - 6 months remote
  • Planet Technology
  • Garland, TX
  • REMOTE EST 6 month contract open to extension and perm hire Join a team as a Biostatistician - act as an independent pro...
  • 3/19/2024 12:00:00 AM

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Regulatory Labeling Specialist
  • Aloe Vera of America, Inc.
  • Dallas, TX
  • Job Description Job Description Regulatory Labeling Specialist - Garland, TX GENERAL DESCRIPTION: As the Regulatory Labe...
  • 3/19/2024 12:00:00 AM

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Health Operations Data Analyst (NOT REMOTE)
  • Watts Healthcare Corporation
  • Fort Worth, TX
  • With over 50 years of service, our goal is to improve the health of the community we serve by creating easier access to ...
  • 3/18/2024 12:00:00 AM

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TRAINER SPECIALIST
  • The Judge Group
  • Fort Worth, TX
  • Can you cut it with the industry leaders in meat portioning and cooking? We re always looking for sharp minds and sure h...
  • 3/18/2024 12:00:00 AM

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Global Regulatory Affairs Manager II
  • Yoh, A Day & Zimmermann Company
  • Fort Worth, TX
  • Job Description Job Description Global Regulatory Affairs Manager II - Fort Worth 9 month contract W2 Pay Rate: $55.00 -...
  • 3/17/2024 12:00:00 AM

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SQF Practitioner
  • Clifco Spice Sales, Inc
  • Mansfield, TX
  • Job Description Job Description We are seeking an SQF Practitioner to become an integral part of our team! . Assist in t...
  • 3/17/2024 12:00:00 AM

Fort Worth is located in North Texas, and has a generally humid subtropical climate. It is part of the Cross Timbers region; this region is a boundary between the more heavily forested eastern parts and the rolling hills and prairies of the central part. Specifically, the city is part of the Grand Prairie ecoregion within the Cross Timbers. According to the United States Census Bureau, the city has a total area of 349.2 square miles (904 km2), of which 342.2 square miles (886 km2) is land and 7.0 square miles (18 km2) is covered by water. It is a principal city in the Dallas–Fort Worth metropl...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$133,872 to $188,825
Fort Worth, Texas area prices
were up 2.2% 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