Regulatory Affairs Specialist jobs in Grand Rapids, MI

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)

Recently Added Regulatory Affairs Specialist jobs

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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.
  • 8 Days Ago
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C
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...
  • 9 Days Ago
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RN Clinical Regulatory Compliance Specialist
  • Corewell Health
  • Grand Rapids, MI FULL_TIME
  • This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Big Rapids, Reed City, and Greenville Hospitals.About Corewell...
  • 6 Days Ago
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RN Clinical Regulatory Compliance Specialist
  • Corewell Health
  • Grand Rapids, MI FULL_TIME
  • This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Grand Rapids Hospitals.About Corewell HealthOur new name signa...
  • 8 Days Ago
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Senior Global Regulatory Specialist- Grand Rapids or Remote/Hybr
  • SunMed LLC
  • Grand Rapids, MI FULL_TIME
  • COMPANY DESCRIPTIONAt AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tagline, but the way we work and take care of our customers. With a...
  • 19 Days Ago
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A
Cosmetic Merchandiser
  • Apollo Retail Specialist
  • Grand Rapids, MI PART_TIME
  • As a cosmetic merchandiser, you’ll take on project-based work to ensure cosmetic products, graphics, and displays are visually appealing to attract and engage shoppers, build strong relationships with...
  • 19 Days Ago
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0 Regulatory Affairs Specialist jobs found in Grand Rapids, MI area

About Grand Rapids, Michigan

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 Specialist jobs
$73,676 to $98,737
Grand Rapids, Michigan area prices
were up 1.3% from a year ago
View detail

What does a Regulatory Affairs Specialist do?

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
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