Regulatory Affairs Manager jobs in Grand Rapids, MI

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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Regulatory Affairs Assistant (START Midwest)
  • Cancer & Hematology Centers of Western Michigan
  • Grand Rapids, MI FULL_TIME
  • Regulatory Affairs Assistant- START Midwest
    General Summary
    Under general supervision of the Regulatory Affairs Specialist, this position is responsible for various administrative duties in the regulatory department.
    Job Requirements
    Education: High School Diploma
    Experience: At least two years’ experience in administrative setting. Proficient working knowledge of Microsoft Word. Strong organizational skills and a sense of timeliness in completing projects; detail-oriented. Good spelling, composition and proofreading skills (medical terminology a plus, but not required). Must be able to complete tasks with minimal supervision and have ability to understand instructions, compose reports and correspondence.

    Primary Duties and Responsibilities (Essential Functions)
    • Stamp and distribute all incoming departmental mail
    • Prepare file folders for all new studies
    • Maintain regulatory files (paper and electronic), including IRB submissions and correspondence
    • Review, process and/or submit IND Safety reports, SUSAR reports, and other interim safety reports to the IRB
    • Process and/or submit SAE reports to the IRB
    • Grant and maintain monitor access to SharePoint
    • Oversee monitor visits (ensure files are up to date, print quality assurance comment cards for each study, be available to answer questions from monitors, etc)
    • Review, obtain signatures (if needed), and file incoming monitor letters
    • Obtain signatures on Delegation of Authority logs (or similar logs) from appropriate personnel
    • Maintain and request updated laboratory documents (CLIAs, CAPs, Director CVs/MLs, normal ranges) for core laboratories
    • Review incoming lab reports for outside laboratories and request laboratory documents
    • Share responsibility with other Regulatory Affairs staff to note changes in FileMaker database (personnel, study monitors, etc)
    • Perform other duties as assigned
    Work Environment
    Able to see clearly in an environment which is equipped with typical lighting. Able to perform manual tasks that require the use of fine muscle motor skills. Able to stand and or sit for prolonged periods. Able to access, input and retrieve information from computer. Very fast-paced and ever changing office environment.
  • 11 Days Ago

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Regulatory Affairs Assistant- START Midwest
  • Cancer & Hematology Centers of Western Michigan
  • Grand Rapids, MI FULL_TIME
  • Regulatory Affairs Assistant- START Midwest General Summary Under general supervision of the Regulatory Affairs Specialist, this position is responsible for various administrative duties in the regula...
  • 12 Days Ago

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Manager of Regulatory and PPS Compliance
  • Mary Free Bed Rehabilitation Hospital
  • Grand Rapids, MI FULL_TIME
  • Employment Value Proposition At Mary Free Bed, we take pride in our values-based culture: · Diversity, Equity, and Inclusion. Our Commitment to providing an inclusive environment for patients, familie...
  • 20 Days Ago

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Regulatory Compliance Manager - Small Engines - Onsite
  • Kawasaki Motors Corp., U.S.A.
  • Grand Rapids, MI FULL_TIME
  • Are you looking for an organization that empowers its team members to learn, grow and make a genuine impact? Is work/life balance important to you? At Kawasaki, we offer this and so much more. The Eng...
  • 6 Days Ago

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Registered Nurse P11
  • State of Michigan - Department of Military and Veterans Affairs
  • Grand Rapids, MI FULL_TIME
  • Excellent State of Michigan Benefits! 13 paid holidays, 401K with large match. Vacation and sick time accrued every pay period of at least 4 hours each. 5000.00 sign on bonus. Responsible for the dire...
  • 21 Days Ago

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US E- Advisory – Manager - Contract Lifecycle Management (Icertis) - Regulatory &Legal Support
  • Deloitte US
  • Grand Rapids, MI FULL_TIME
  • Legal Business Services – Manager – Contract Lifecycle Management (Icertis)Deloitte Discovery’s Legal Business Services (LBS) teams provide a comprehensive suite of legal management consulting, inform...
  • 1 Month Ago

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0 Regulatory Affairs Manager jobs found in Grand Rapids, MI area

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Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Grand Rapids, MI
  • 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

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Radiopharmacy Operations Specialist
  • BAMF Health
  • Grand Rapids, MI
  • Join BAMF Health, where you're not just part of a team; you're at the forefront of a revolution in Theranostics, changin...
  • 4/26/2024 12:00:00 AM

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Regulatory Specialist
  • BAMF Health
  • Grand Rapids, MI
  • Join BAMF Health, where you're not just part of a team; you're at the forefront of a revolution in Theranostics, changin...
  • 4/26/2024 12:00:00 AM

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Program Supervisor, Home Study/Post Release Services
  • Catholic Charities West Michigan
  • Grand Rapids, MI
  • Position Summary: The Home Study/Post Release Services Program Supervisor is primarily responsible for overseeing case s...
  • 4/24/2024 12:00:00 AM

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Specialist Record Review
  • Versiti, Inc.
  • Grand Rapids, MI
  • Overview: Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood ...
  • 4/23/2024 12:00:00 AM

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Senior Manager , Software Engineering, Full Stack
  • Capital One
  • Grand Rapids, MI
  • 77 West Wacker Dr (35012), United States of America, Chicago, Illinois Senior Manager , Software Engineering, Full Stack...
  • 4/23/2024 12:00:00 AM

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Principal Associate, Data Loss Prevention (DLP) Engineer
  • Capital One
  • Grand Rapids, MI
  • Center 3 (19075), United States of America, McLean, Virginia Principal Associate, Data Loss Prevention (DLP) Engineer Ca...
  • 4/23/2024 12:00:00 AM

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Lead Software Engineer, Back End (Golang, AWS)
  • Capital One
  • Grand Rapids, MI
  • West Creek 2 (12072), United States of America, Richmond, Virginia Lead Software Engineer, Back End (Golang, AWS) Do you...
  • 4/22/2024 12:00:00 AM

Grand Rapids is the second-largest city in Michigan, and the largest city in West Michigan. It is on the Grand River about 30 miles (48 km) east of Lake Michigan. As of the 2010 census, the city population was 188,040. In 2010, the Grand Rapids metropolitan area had a population of 1,005,648, and the combined statistical area of Grand Rapids-Muskegon-Holland had a population of 1,321,557. Grand Rapids is the county seat of Kent County. A historic furniture-manufacturing center, Grand Rapids is home to five of the world's leading office furniture companies, and is nicknamed Furniture City. Its ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$133,626 to $188,488
Grand Rapids, Michigan area prices
were up 1.3% 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