Regulatory Affairs Specialist jobs in Maryland

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)

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Senior Editor, Books
  • Regulatory Affairs Professionals Society
  • Rockville, MD FULL_TIME
  • Location:  Rockville, MD (hybrid or fully remote) 

    Key skills:  Substantive editing, author management, content management 

    Experience:  8-10 years editorial experience in book publishing 

    Reports to:  Director, Publications 

    Start date:  February 2024 

    Applicants who are invited to interview will be asked to provide a writing sample. 

     

    The Role 

    Help support the professionals who bring lifesaving medications and medical devices to market! RAPS (the Regulatory Affairs Professionals Society) is seeking a senior editor to shepherd subject matter experts and shape the content they create for books and related products. 

     

    What you will do with us: 

    • Serve as editor on books published by RAPS. 
    • Evaluate book proposals and manuscripts; supervise the submission process and tracking system. 
    • Substantively edit manuscripts for factual accuracy, form, grammar/punctuation, adherence to proscribed style, and general readability. 
    • Oversee book contracts and author agreements. 
    • Serve as staff liaison to the volunteer Editorial Advisory Committee (EAC) on developing the annual book production calendar. 
    • Research and develop new books and resources on topics of interest to the regulatory community, including RAPS-published and co-published books. 
    • Work with graphic designers on book layout and design. 
    • Work with editorial freelancers on quality control. 
    • Liaison with the marketing team to ensure they are adequately backgrounded to develop compelling tactics to foster book sales.
    • Liaison with external organizations for potential co-promotion of books and other publications. 
    • Support other editorial and communications activities of the organization, as appropriate. 

     

    What you will bring to succeed: 

    • Bachelor’s degree in English, communications, journalism, or related; OR commensurate experience 
    • 8 to 10 years of editorial experience in book publishing 
    • Strong written and verbal communication skills 
    • Ability to establish working relationships both internally and externally 
    • Strong author management skills 
    • Highly skilled in time management and organization 
    • Multitasker; able to meet or exceed deadlines on multiple projects simultaneously 
    • Thorough understanding of print and electronic publication production processes 
    • Excellent attention to detail 
    • Proficiency in Microsoft Office 
    • Working knowledge of several professional editorial-style manuals 

    Preferred: 

    • Familiarity with regulatory, medical, and/or scientific topics 
    • Knowledge of InDesign, InCopy, or other layout production software 

     

    What RAPS offers: 

    • Flexible hybrid work environment 
    • Highly competitive, market-based salaries 
    • Annual merit-based salary adjustments 
    • Incentive pay/bonuses 
    • Reimbursement for job-related education training 
    • Fully paid LinkedIn Learning subscription 
    • Generous PTO accruement 
    • 10 annual paid holidays with extended holiday break 
    • Medical, dental, vision, & life insurance 
    • Short/long term disability 
    • 403(b) Retirement Plan with employer match 

     

    About RAPS 

    The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, DC, with chapters and affiliates worldwide.

     

    As an employer, RAPS encourages dedication to quality and member service. We support innovation and creativity, respect, and high ethical standards. We value learning and professional development and strive to maintain a safe and enjoyable work atmosphere that promotes collegiality.

     

    RAPS provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable laws. RAPS complies with applicable state and local laws governing nondiscrimination in employment in every location where the company has facilities.

     

    We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

  • 2 Days Ago

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Marketing Manager, Professional Development & Publications
  • Regulatory Affairs Professionals Society
  • Rockville, MD FULL_TIME
  • Location: Rockville, MD (hybrid or fully remote) Key skills: Multi-channel marketing, marketing campaign development, copywriting Experience: 5 years’ experience in strategic marketing Reports to: Dir...
  • 1 Month Ago

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Quality / Regulatory Affairs Specialist
  • MRIGlobalSearch
  • Timonium, MD FULL_TIME
  • What's in it for you... Small company - make a large impact on the business Stable company with a successful product line - long history of success Well established company - medical device great indu...
  • 23 Days Ago

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Baltimore, MD FULL_TIME
  • Responsibilities : Provide regulatory guidance to product development teams for assigned brands, including claim substantiation, label reviews and advice on regulatory submissions. Maintain and prepar...
  • 23 Days Ago

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • East Case, MD FULL_TIME
  • Responsibilities: Provide regulatory guidance to product development teams for assigned brands, including claim substantiation, label reviews and advice on regulatory submissions. Maintain and prepare...
  • 6 Days Ago

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Regulatory Affairs Specialist
  • Sunstone Therapies
  • Rockville, MD FULL_TIME
  • Context: Sunstone Therapies is the leader in the delivery of psychedelic-assisted therapy in the medical setting, focusing on the development and implementation of clinical trials today, and moving to...
  • 13 Days Ago

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Regulatory Affairs Specialist
  • Sally Beauty Holdings, Inc.
  • Denton, TX
  • Review labels of private label products for regulatory compliance in the US and applicable international markets. Review...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL
  • Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electroni...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • ConvaTec
  • Lexington, MA
  • Product Regulatory Affairs work includes: Directing submission development of product registration, progress reports, su...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Tephra
  • Cincinnati, OH
  • Description: The candidate will work with client & Client teams to deliver best in-class solutions for regulatory submis...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Akkodis
  • Irvine, CA
  • Akkodis is seeking an Regulatory Affairs Specialist for a company located in Candidates need to be local to a Irvine ,CA...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Tephra
  • Edison, NJ
  • Description: The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • The Judge Group
  • Horsham, PA
  • Regulatory Affairs Specialistreq38824Employment Type: RegularLocation: HORSHAM,PAHave you ever enjoyed Arnold, Brownberr...
  • 3/26/2024 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 Specialist jobs
$78,050 to $104,598

Regulatory Affairs Specialist in Petaluma, CA
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
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019