Regulatory Affairs Director jobs in Baltimore, MD

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 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 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
  • 26 Days Ago

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Regulatory Affairs Manager
  • Tobacco Technology
  • Eldersburg, MD FULL_TIME
  • About Tobacco Technology, Inc (TTI): More than 150 years ago, we began our tobacco journey as tobacco farmers, eventually becoming a premier exporter of leaf tobacco in the USA. And for the last 50 ye...
  • 1 Month Ago

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Regulatory Affairs Specialist, Medical Device
  • Katalyst Healthcares & Life Sciences
  • Baltimore, MD FULL_TIME
  • Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have ...
  • 1 Month Ago

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Director Quality & Regulatory
  • Aphena Pharma Solutions
  • Easton, MD OTHER
  • Job Details Job Location: Liquid & Topicals Division - Maryland - Easton, MD Salary Range: $130,000.00 Salary/year DescriptionPosition Summary The Director of Quality is responsible for the developmen...
  • 1 Month Ago

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Director, Government Affairs
  • mccormickt3.valhalla.stage
  • HUNT VALLEY, MD FULL_TIME
  • You may know McCormick as a leader in herbs, spices, seasonings, and condiments – and we’re only getting started. At McCormick, we’re always looking for new people to bring their unique flavor to our ...
  • 1 Day Ago

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Director of Student Intercultural Affairs
  • Washington College
  • Chestertown, MD FULL_TIME
  • Washington College is seeking a visionary leader to grow its programs and transform the Intercultural Center into a vital cultural hub for Washington College’s student body; supporting not only the so...
  • 1 Month Ago

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0 Regulatory Affairs Director jobs found in Baltimore, MD area

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Director of Regulatory Affairs
  • Flexible Packaging Association
  • Annapolis, MD
  • Job Description Job Description Responsibilities • Identify, manage, and respond to all regulatory proposals impacting m...
  • 4/19/2024 12:00:00 AM

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Director, Organ Recovery
  • Infinite Legacy
  • Baltimore, MD
  • General Job Summary: Under the general direction of the VP & Chief Clinical Officer, the Director, Organ Recovery leads ...
  • 4/19/2024 12:00:00 AM

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Director Central Sterile Processing
  • University of Maryland Medical System
  • Baltimore, MD
  • Company Description Renowned as the academic flagship of the University of Maryland Medical System, our Magnet-designate...
  • 4/19/2024 12:00:00 AM

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Director, Global Regulatory Affairs, Vaccines
  • GlaxoSmithKline
  • Rockville, MD
  • Site Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Apr 11 2024 Are you looking fo...
  • 4/18/2024 12:00:00 AM

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Director, CMC Regulatory Affairs
  • GlaxoSmithKline
  • Rockville, MD
  • Site Name: USA - Pennsylvania - Upper Providence, Cambridge MA, GSK House, Stevenage, Upper Merion, USA - Maryland - Roc...
  • 4/17/2024 12:00:00 AM

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Energy Program Manager - Energy Efficiency and Electrification
  • Maryland Energy Administration
  • Baltimore, MD
  • This is an expedited recruitment, please apply no later than April 24th, 2024 for best consideration. Two or More Positi...
  • 4/17/2024 12:00:00 AM

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Energy Program Manager - Community Energy Programs
  • Maryland Energy Administration
  • Baltimore, MD
  • This is an expedited recruitment, please apply no later than April 24th, 2024 for best consideration. Join the Maryland ...
  • 4/16/2024 12:00:00 AM

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Director, Strategic Sourcing & Preference Program Management
  • Maryland Department of General Services
  • Baltimore, MD
  • DIRECTOR, Strategic Sourcing & Preference Program Management (Procurement Manager IV) Maryland Department of General Ser...
  • 4/15/2024 12:00:00 AM

Baltimore (/ˈbɔːltɪmɔːr/) is the largest city in the state of Maryland within the United States. Baltimore was established by the Constitution of Maryland as an independent city in 1729. With a population of 611,648 in 2017, Baltimore is the largest such independent city in the United States. As of 2017[update], the population of the Baltimore metropolitan area was estimated to be just under 2.808 million, making it the 20th largest metropolitan area in the country. Baltimore is located about 40 miles (60 km) northeast of Washington, D.C., making it a principal city in the Washington-Baltimo...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$173,759 to $247,473
Baltimore, Maryland area prices
were up 1.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020