Top 463 Regulatory specialist Jobs in Baltimore, Md

Regulatory Specialist II (Cardiology)
Johns Hopkins University —Baltimore, MD
- $41,300 - $72,300 a year
- Full-time
- Background check
- Mid-level
- University
Regulatory Specialist II (Oncology)
Johns Hopkins University —Baltimore, MD
- $41,300 - $72,300 a year
- 8 hour shift
- Hybrid work
- Background check
- Mid-level
- University
Specialist III - Attendance
Baltimore City Public Schools —Baltimore, MD
- $85,709 - $129,933 a year
- Online Application
- School experience
- Microsoft Excel
- 3 years
4d
Regulatory Specialist
Stantec —Laurel, MD
- $80,300 - $116,500 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Wellness program
- Health savings account
Regulatory Affairs Specialist (Innovation)
BD —Sparks, MD
- $95,900 - $153,400 a year
- Microsoft Excel
- 5 years
- Mid-level
Clinical Documentation Integrity Specialist
Luminis Health —Annapolis, MD
- $93,120 - $136,344 a year
- Full-time
- RN License
- 5 years
- Computer literacy
- AD&D insurance
- Paid holidays
1d
Quality and Patient Safety Specialist
Greater Baltimore Medical Center, Inc. —Baltimore, MD
- $74,965.56 - $127,441.45 a year
- Full-time
- Acute care
- Nursing
- Microsoft Outlook
Quick Apply
Scheduler & Authorization Specialist
OrthoMaryland —Baltimore, MD
- Remote
- English
- Mid-level
- High school diploma or GED
Quick Apply
2d
Retail Quality Assurance Specialist I
Ahold Delhaize USA —Glen Burnie, MD
- $72,880 - $109,320 a year
- Full-time
- Microsoft Word
- Computer literacy
- Mid-level
Retirement Specialist
Kennedy Krieger Institute —Baltimore, MD
- $64,501.01 - $114,089.46 a year
- Full-time
- 3 years
- Continuous improvement
- Senior level
- 401(k)
4d
Senior Regulatory Affairs Specialist (Columbia, MD)
Smith & Nephew —Columbia, MD
- $101,500 - $152,250 a year
- 8 hour shift
- Hybrid work
- 5 years
- Bachelor's degree
- Continuous improvement
- Health savings account
- Paid holidays
Supervisory Health System Specialist
US Military Treatment Facilities under DHA —Annapolis, MD
- $102,415 - $133,142 a year
- Online Application
- Background check
- Management
- Pass drug screening
5d
Payment Policy Analyst (Remote)
CareFirst BlueCross BlueShield —Baltimore, MD
- $58,320 - $115,830 a year
- Full-time
- Remote
- Nursing
- Microsoft Excel
- Mid-level
- 401(k)
Quick Apply
Senior Portfolio Analyst – US Equity Large Cap Value
T. Rowe Price —Baltimore, MD
- $100,000 - $160,000 a year
- Full-time
- Hybrid work
- 5 years
- Office
- Master's degree
- Paid time off
- Adoption assistance
Senior Behavioral Health Specialist
MedStar Health —Baltimore, MD
- $35.68 - $58.84 an hour
- Part-time
- Children
- Psychology
- ER
Payroll and HR Operations Specialist
Gaines and Company —Reisterstown, MD
- $65,000 - $75,000 a year
- Full-time
- Background check
- Spanish
- Construction site
- Health insurance
- Dental insurance
Quick Apply
5d
Nurse Professional Development Specialist ( Cardiovascular ICU )
MedStar Health —Baltimore, MD
- $42.82 - $71.16 an hour
- Full-time
- CPR Certification
- Nursing
- RN License
Quick Apply
Occupational Therapist Specialist
Elizabeth Cooney Personnel Agency, Inc. —Towson, MD
- $90 - $100 an hour
- Contract
- Computer literacy
- Physical & Rehabilitation Medicine
- HIPAA
Quick Apply
4d
Acquisition Specialist
VISTA Technology Services —Fort Meade, MD
- $65,000 - $80,000 a year
- Hybrid work
- Mid-level
- Bachelor's degree
- Contracts
- Disability insurance
- Health insurance
Payroll Specialist
Road Runner Wrecker Service —Windsor Mill, MD
- $30 - $32 an hour
- Full-time
- Research
- Mid-level
- Administrative experience

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Regulatory Specialist II (Cardiology)

Johns Hopkins University -
Baltimore, MD

Apply Now

Job Details

Full-time
$41,300 - $72,300 a year

Qualifications

FDA regulations

Full Job Description

Affiliated Office Address

Baltimore, MD, United States

Requisition ID

121656

Date Created

June 25, 2026

Job Family

Research

Job Subfamily

Research Administration

Job Function

Research

Exempt Status

Exempt

Shift Type

Full Time

Schedule

M-F, 8:30 am - 5:00 pm

Worksite

04-MD:School of Medicine Campus

Work Modality

Hybrid: On-site 60-89% of hours worked (Ex: 3-4 out of 5 days/week)

We are seeking a Regulatory Specialist II who will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. This role will serve as a central resource for faculty conducting clinical research.

Specific Duties & Responsibilities

Collaborate with the Research Nurse and/or Principal Investigator to ensure timely and accurate submissions to the IRB and study sponsors.
Obtain and prepare all required documents for new IRB submissions, including initial study submissions.
Oversee the smooth implementation of new clinical trials from study conception through activation.
Coordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation.
Collect all required regulatory documents from participating sites when JHU/JHM serves as the coordinating center, ensuring timely collection
Develop and maintain standard operating procedures (SOPs).
Support auditing and monitoring activities, including those involving external sites.
Act as a central resource for faculty conducting clinical research.
Prepare and manage required regulatory documentation, including financial disclosure forms, delegation logs, FDA Form 1572, and others.
Maintain an organized regulatory binder (electronic or physical), initiating with required documents and structured for ongoing updates.
Ensure prompt reporting of serious adverse events (SAEs) and protocol deviations in accordance with applicable regulations.
Track protocol submissions through the IRB and relevant subcommittees, identifying bottlenecks and implementing process improvements.
Attend and contribute to study start-up meetings.
Participate in routine and as-needed monitoring visits.
Assist in preparation for and follow-up of regulatory inspections and audits.
Other duties as assigned.

In addition to the duties described above

Coordinate day-to-day clinical trial activities to ensure protocol adherence and efficient study execution.
Support participant screening, enrollment, and scheduling of study visits in collaboration with study teams.
Maintain accurate source documentation and ensure timely, high-quality data entry into study databases.
Assist with safety reporting, including adverse event and protocol deviation documentation, in accordance with regulatory requirements.
Facilitate communication among investigators, study staff, sponsors, CROs, and institutional partners to support ongoing trial operations.
Prepare for and support sponsor monitoring visits, audits, and study close-out activities.

Minimum Qualifications

Bachelor's Degree.
Two years of experience in academic, government, or industry-based clinical research.

Familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research.

Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

Classified Title: Regulatory Specialist II
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted: commensurate w/exp.)
Employee group: Full Time
Schedule: M-F, 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: Hybird/ School of Medicine Campus
Department name: SOM DOM Cardiology
Personnel area: School of Medicine

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/.

Education and Experience Equivalency
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.

Applicants Completing Studies
Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.

Background Checks
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

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.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at [email protected]. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit: https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

Apply Now

Refine Your Search

regulatory specialist jobs in baltimore, md

Regulatory Specialist II (Cardiology)

Regulatory Specialist II (Oncology)

Specialist III - Attendance

Regulatory Specialist

Regulatory Affairs Specialist (Innovation)

Clinical Documentation Integrity Specialist

Quality and Patient Safety Specialist

Scheduler & Authorization Specialist

Retail Quality Assurance Specialist I

Retirement Specialist

Senior Regulatory Affairs Specialist (Columbia, MD)

Supervisory Health System Specialist

Payment Policy Analyst (Remote)

Senior Portfolio Analyst – US Equity Large Cap Value

Senior Behavioral Health Specialist

Payroll and HR Operations Specialist

Nurse Professional Development Specialist ( Cardiovascular ICU )

Occupational Therapist Specialist

Acquisition Specialist

Payroll Specialist

I want to receive the latest job alert for regulatory specialist in baltimore, md

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