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Regulatory Assistant Jobs in Racine, WI (NOW HIRING)

Milwaukee Tool

Regulatory Engineer

Brookfield, WI · On-site

Your primary duty is to assist in the coordination and execution of Regulatory and compliance testing and evaluation of Milwaukee products to the provisions of US, Canadian, and International product ...

Milwaukee Tool

Regulatory Engineer

Brookfield, WI · On-site

Your primary duty is to assist in the coordination and execution of Regulatory and compliance testing and evaluation of Milwaukee products to the provisions of US, Canadian, and International product ...

Milwaukee Tool

Regulatory Engineer

Brookfield, WI

Your primary duty is to assist in the coordination and execution of Regulatory and compliance testing and evaluation of Milwaukee products to the provisions of US, Canadian, and International product ...

Add to Life, Inc.

Personal Care Worker

Milwaukee, WI · On-site

$16.40/hr

Provide medication reminders (as allowed by state regulations) * Assist with shopping and errands * Provide companionship and emotional support * Observe and report changes in client's condition

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Regulatory Assistant information

See Racine, WI salary details

$31.9K

$55.3K

$107.4K

How much do regulatory assistant jobs pay per year?

As of Sep 6, 2026, the average yearly pay for regulatory assistant in Racine, WI is $55,305.00, according to ZipRecruiter salary data. Most workers in this role earn between $38,400.00 and $72,200.00 per year, depending on experience, location, and employer.

What is a regulatory assistant?

A regulatory assistant has a crucial job in any research lab, seeing that every step of a clinical study follows regulations. As a regulatory assistant, your duties include keeping up to date with regulations and ensuring that everyone in the lab follows the correct procedures. You may also collect and prepare lab samples and maintain various documents. You provide a valuable service, serving as a liaison between a laboratory and regulatory agencies. Qualifications typically include a bachelor’s degree in a relevant scientific field, although a master’s degree is sometimes preferred. To be successful in this career, you need strong communication and time-management skills, attention to detail, and prior office experience working with a team.

What are the key skills and qualifications needed to thrive as a regulatory assistant, and why are they important?

To thrive as a Regulatory Assistant, you need strong organizational skills, attention to detail, and a relevant degree such as in life sciences, law, or business administration. Familiarity with regulatory databases, document management systems, and sometimes certifications like RAC (Regulatory Affairs Certification) are commonly required. Excellent communication, time management, and problem-solving abilities are crucial soft skills for this role. These competencies ensure accurate regulatory submissions, timely compliance, and effective coordination with regulatory agencies and internal teams.

What are some common challenges faced by regulatory assistants during the document submission process?

Regulatory Assistants often encounter challenges such as managing tight deadlines, ensuring complete accuracy in documentation, and keeping up-to-date with frequently changing regulations. Coordinating with multiple departments to gather required information can also be complex, especially when timelines are short or requirements are ambiguous. Strong organizational skills and attention to detail help Regulatory Assistants navigate these obstacles and ensure successful, timely submissions.

What is the difference between Regulatory Assistant vs Compliance Coordinator?

AspectRegulatory AssistantCompliance Coordinator
Required CredentialsAssociate's degree, certifications like RAC or RAPS often preferredBachelor's degree, certifications like RAC or RAPS common
Work EnvironmentOffice setting, supporting regulatory teams in healthcare, pharmaceuticals, or medical devicesOffice setting, overseeing compliance programs in similar industries
Employer & Industry UsageUsed by pharmaceutical, biotech, medical device companiesUsed by healthcare, pharmaceutical, and medical device firms
Search & Comparison IntentOften compared for entry-level regulatory rolesRelated to regulatory roles but with broader compliance responsibilities

The Regulatory Assistant primarily supports regulatory teams by preparing documentation and ensuring compliance with regulations. The Compliance Coordinator has a broader role, overseeing compliance programs and policies. While both roles require similar credentials and work in related industries, the Compliance Coordinator typically has more responsibility for overall compliance management.

Is regulatory assistant high paying?

Regulatory assistants typically earn a median salary that is moderate compared to other administrative or compliance roles, with pay often influenced by experience, location, and industry. While some positions may offer competitive wages, the role generally does not fall into the high-paying job category. Certifications and specialized knowledge can impact earning potential.
More about Regulatory Assistant jobs

What are the most commonly searched types of Regulatory jobs in Racine, WI?

The most popular types of Regulatory jobs in Racine, WI are:

Regulatory Assistant jobs near you

Research Regulatory Specialist - Pediatrics

Medical College of Wisconsin

Milwaukee, WI • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 5 days ago

Medical College Of Wisconsin rating

7.7

Company rating: 7.7 out of 10

Based on 29 frontline employees who took The Breakroom Quiz

265th of 631 rated colleges and universities

Job description

Summary
The Research Regulatory Specialist is responsible for gathering regulatory documents and preparing IRB applications, amendments, and continuing review submissions for human subject research, ensuring compliance with Federal, State, and Institutional Standard Operating Procedures. This role serves as the regulatory liaison with sponsors, principal investigators, study team members, and the IRB to support the successful conduct of research projects.
Primary Responsibilities
  • Provide primary administrative support for the preparation of IRB documents. Assist in drafting and submitting protocols, protocol summaries, amendments, protocol deviations, serious adverse events, continuing progress reports, and consent documents. Modify documents as needed to meet IRB guidelines and research program requirements.

  • Prepare and submit required documents in the institution's electronic IRB system for initial approval, amendments, and continuing progress reports. Review submissions for accuracy, completeness, and compliance using established checklists prior to submission.

  • Support faculty with Investigator-Initiated IND/IDE applications. Maintain IRB and FDA regulatory files for each IND/IDE and ensure required routine monitoring is conducted.

  • Facilitate study start-up activities, including submissions to committees such as the Scientific Review Committee, Data Safety Monitoring Board, Institutional Biosafety Committee, or Radiation Safety Committee. Manage ClinicalTrials.gov postings as required.

  • Collaborate with Research Managers, Research Nurses, and Research Coordinators to identify and complete all regulatory needs for assigned protocols.

  • Identify and resolve problems or obstacles related to research protocol implementation. Communicate issues to supervisors and study investigators.

  • Ensure all regulatory activities comply with applicable federal and state laws, as well as institutional standard operating procedures.

  • Assist investigators and research staff with the development of program materials, including educational materials, marketing content, websites, forms, and reports.

  • Maintain program timelines by tracking deadlines for program components. Utilize the institution's Clinical Trial Management System (CTMS) to meet regulatory requirements and track activities. Collect, analyze, and disseminate program data, and report progress to stakeholders.

  • Coordinate notifications to study team members regarding annual regulatory education requirements.

  • Work with principal investigators to develop, implement, and maintain comprehensive databases and files related to the research program.

  • Other duties as assigned.

Knowledge - Skills - Abilities
  • Excellent oral and written communication skills are essential.

  • Strong critical thinking, problem-solving, and attentiveness to detail required.

  • Additional training in regulatory compliance strongly preferred.

Qualifications
Appropriate experience may be substituted for education on an equivalent basis.
Minimum Required Education: Bachelor's degree.
Minimum Required Experience: 2 years in compliance or healthcare field
Preferred Education: 2 years in compliance or healthcare field
Required Certification/Licensure(s): CITI certification required within 30 days of hire
Preferred Certification/Licensure(s): SoCRA and ACRP certification preferred.
Physical Requirements
Work requires occasionally lifting moderate weight materials, standing, or walking continuously.
Work Environment
Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids. Work is performed in an environmentally controlled environment.
Sensory Acuity
Ability to detect and translate speech or other communication required. May occasionally require the ability to distinguish colors and perceive relative distances between objects.
#LI-AV1
Why MCW?
  • Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
  • 403B Retirement Package
  • Competitive Vacation and Paid Holidays offered
  • Tuition Reimbursement
  • Paid Parental Leave
  • Employee & Family Assistance Program (EFAP)
  • Pet Insurance
  • On campus Fitness Facility, offering onsite classes
  • Additional discounted rates on items such as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a brief overview of our benefits see: Benefits Overview
For a full list of positions see: MCW Careers
At MCW all of our endeavors, from our internal operations to our interactions with our partners, are driven by our shared organizational values: Caring - Collaborative - Curiosity - Inclusive - Integrity - Respect. We are committed to fostering an inclusive environment that values diversity in backgrounds, experiences, and perspectives through merit-based processes and in alignment with all applicable laws. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. Our values define who we are, what we stand for and how we conduct ourselves at MCW. If you believe in embracing individuality and working together according to these principles to improve health for all, then MCW is the place for you. For more information, please visit our institutional website.
MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination:
The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering an inclusive community of outstanding faculty, staff, and students, as well as ensuring equal educational opportunity, employment, and access to services, programs, and activities, without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.

What Medical College Of Wisconsin employees say

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Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

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About Medical College of Wisconsin

Sourced by ZipRecruiter

The Medical College of Wisconsin (MCW) is an industry-leading educational institution located in Milwaukee, WI, US. Being part of the medical and health services sector, MCW's primary mission is to educate and train the next generation of healthcare professionals. MCW offers a wide array of degrees and programs within medical and health sciences, covering everything from medical, graduate, pharmacy and health sciences studies, to continuing professional developments and community engagement initiatives. Founded in 1893, MCW boasts a rich, well-entrenched history in shaping the medical education landscape locally and globally. The institution's core values of knowledge-changing life underline its dedication to incorporating innovative approaches in education and research, commitment to diversity and inclusion, service to the community, integrity, stewardship, and collaboration.

Industry

Health care and social assistance

Company size

5,001 - 10,000 Employees

Headquarters location

Milwaukee, WI, US

Year founded

1893

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