Regulatory Affairs Director jobs in Maryland

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Director of Regulatory Affairs
  • Johns Hopkins Howard County Medical Center
  • Columbia, MD FULL_TIME
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    Job Details

    Requisition #:639749 Location:Johns Hopkins Howard County Medical Center, Columbia, MD 21044 Category:Leadership Schedule:Day Shift

    Job Summary

    The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification processes, including but not limited to, The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), and State/Local Department of Health (DOH) standards, regulations and law, in consultation with JHHS Legal Counsel, as necessary. This position involves interpreting and operationalizing regulatory requirements, including but not limited to:

    • Participating in regulatory-related communication/notification, staff/leadership education, and policy/documentation development or revision as needed.
    • Coordinating virtual and onsite surveys by external regulatory/accreditation agencies
    • Coordinating onsite mock surveys by external consultants or JHHS Office of Accreditation & Certification (OAC)
    • Developing and implementing corrective actions and monitoring plans for sustaining improvements over time
    • Collaborating on special projects, as requested
    • Serving as a resource/consultant to internal and external customers
    • Participating in organization and/or health system committees

    Qualifications

    • Requires a Master’s Degree (healthcare-related preferred). Graduation from an accredited school of nursing, public health or related clinical discipline preferred.
    • A minimum of 8 – 10 years of healthcare-related experience required with current knowledge of accreditation/certification processes and performance improvement tools and techniques
    • At least 2 years of direct management experience
    • Experience in regulatory compliance, performance/quality improvement, patient safety, risk management or project management preferred.
    • Licensed or certified in a healthcare related field
    • Certified Professional in Healthcare Quality (CPHQ) preferred

    Johns Hopkins Health System and its affiliates are an Equal Opportunity / Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.

    Apply
  • 5 Days Ago

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Director Regulatory Affairs
  • Alpha Consulting Corp.
  • Gaithersburg, MD OTHER
  • Director Regulatory Affairs - Late Cardiovascular, Renal and Metabolism Gaithersburg, MD Must Be Able To Work Onsite Pay Range: $99.81 - $103.14/hr W2 Required Skills: Academic degree in a science rel...
  • 9 Days Ago

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Director of Regulatory Affairs
  • Johns Hopkins Medicine
  • Baltimore, MD FULL_TIME
  • Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure c...
  • 19 Days Ago

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Director of Regulatory Affairs
  • Johns Hopkins Medicine
  • Columbia, MD FULL_TIME
  • Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure c...
  • 30 Days Ago

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Director Regulatory Affairs
  • Flexible Packaging Association
  • Annapolis, MD FULL_TIME
  • About the Job The Flexible Packaging Association (FPA), an Annapolis-based trade association representing over 85,000 packaging professionals across the nation, is looking for a Director of Regulatory...
  • 2 Months Ago

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Senior Director, Business Partnering Communications
  • 10000236 - Corporate Affairs Director
  • Gaithersburg, MD FULL_TIME
  • Senior Director, Business Partnering Communications About AstraZenecaAt AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thi...
  • Just Posted

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/11/2024 12:00:00 AM

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Head of Regulatory Affairs
  • EPM Scientific
  • Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
  • 6/10/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/10/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 6/8/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
  • 6/8/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/7/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/7/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Chicago, IL
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/7/2024 12:00:00 AM

Maryland (US: /ˈmɛrələnd/ (listen) MERR-əl-ənd) is a state in the Mid-Atlantic region of the United States, bordering Virginia, West Virginia, and the District of Columbia to its south and west; Pennsylvania to its north; and Delaware to its east. The state's largest city is Baltimore, and its capital is Annapolis. Among its occasional nicknames are Old Line State, the Free State, and the Chesapeake Bay State. It is named after the English queen Henrietta Maria, known in England as Queen Mary. Sixteen of Maryland's twenty-three counties border the tidal waters of the Chesapeake Bay estuary and...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$175,164 to $249,478

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At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
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Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019