Regulatory Affairs Specialist jobs in Ohio
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)
Recently Added Regulatory Affairs Specialist jobs
Regulatory Affairs Specialist
- SIERTEK LTD
-
Dayton, OH
PART_TIME
-
SierTeK proudly serves our clients by providing expertise in the Program Management, Information Technology, and Administrative Support domains. Founded in 2007 as a minority and service-disabled veteran-owned company, we serve as prime- and subcontractor for a multitude of Federal Department of Defense contracts. By focusing on continual improvement, our services remain at the forefront of our industry, and we pride ourselves on delivering our services with the highest degree of integrity.
SierTeK Ltd. is seeking a Regulatory Affairs Specialist to support an opportunity remotely.
Please use the following link to apply to this position: 24-9 Regulatory Affairs Specialist (paycomonline.net)
Position Overview
This position is for a part-time subject matter expert specialist Food and Drug Administration (FDA) regulatory affairs.
Essential Job Functions- Employee shall provide expert technical research FDA-related regulatory review of others' research proposals and be of the kind and sufficient experience that would enable the contractor to independently provide critical guidance to researchers, IRB Program Director, and executive staff regarding human subject research administration, processing, standards and regulations.
- Employee shall independently analyze/evaluate research protocols and coordinate/assist investigators' efforts to guarantee efficient and timely processing of protocols and regulatory compliance and to conduct quality assurance audits of AFRL customers to confirm such regulatory compliance.
- Tasks shall align to ensure that prior education, training and/or experience enables the Contractor to be knowledgeable with federal and Department of Defense IRB administrative requirements. Tasks shall be of a specialized variety and Contractor shall independently apply knowledge of and discharge timely analysis of human subjects research related to a wide-range of regulatory requirements including, but not limited to: 10 USC 980; HHS 45 CFR 46; DoD 32 CFR 219; DoDI 3216.02_AFI 40-402; DODI 6000.08, AFRLI 40-402, as well as 21 CFR, Food, Drug and Cosmetic Act (FD&C Act) and Food and Drug Administration (FDA) regulations and policy related to drug and device research.
- Tasks require high degrees of proficiency in English writing and oral communication. These capabilities, obtained through higher educational academics or experience, shall enable the Contractor to independently draft e-mail and official correspondence as needed to facilitate the administrative and regulatory lifespan of human subject research programs and studies.
- Employee shall develop, plan, host and deliver FDA research regulatory affairs training and education materials in various venues: web-site materials, workshops, training presentations, and quality assurance visits and discussions related to FDA regulatory requirements for researcher data controls.
- Employee shall use prior knowledge, skill, training, experience to independently use a desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems. The Contractor shall perform tasks for 711 HPW/IR within an electronic web-based system and shall train customers on the use of such a system.
- Employee shall interface with the following staff offices: 711th Human Performance Wing (HPW) (USAFSAM and RH), USAF Surgeon General Research Compliance (SGE-C), U.S. Food and Drug Administration (FDA), and their respective related staff/contractors, and other diverse research collaborators.
- Employee shall have at least 5 years' experience applying FDA research regulatory requirements within a research regulatory affairs program office. Work in preparing one's own research proposals and one's own submissions to an IRB office or to the FDA and managing one's own research portfolio will not meet the qualifications required by this section.
- 3-year current (within the past 5 years) personal and direct experience in FDA clinical research protocol compliance administration and shall have personally conducted FDA focused regulatory affairs quality assurance audits of customer's research projects.
- Possess a Bachelor's Degree or Associate's Degree/two years of college plus 2 years of related work experience or 4 years of direct work experience in the field that would provide the experience, knowledge and skills that are needed to perform the work proficiently. Will meet all technical and experience prerequisites to be qualified to test for Regulatory Affairs Professional certification, such as Certified Clinical Research Professional (CCRP), Research Regulatory Affairs Professional (RAP) or other like-kind industry standard certification. Current holder of regulatory affairs professional certification is preferred.2 years current (within the past 3 years) or prior experience in developing IRB protocol submission templates and IRB meeting minutes and agenda for establishment of or continued function of a HRPP office.
- At least 1 year current (within the past 3 years) prior experience in developing or providing detailed consultation on the development of FDA-regulated clinical drug or device research trials, including, but not limited to research involving software as a medical device (SoMD) and off-label research use of FDA-controlled medical devices.
- Employee shall have prior experience in independently drafting FDA research regulatory affairs implementation guidance.
- Employee shall have prior experience in the development, planning, hosting and delivering FDA research regulatory affairs training and education materials, including but not limited to web-site materials, workshops, training presentations, and quality assurance visits and discussions related to administration of clinical trial research records.
- Employee shall have knowledge, skill, training, experience and ability to be proficient in the use of desktop computer workstation for accomplishment of tasks in Microsoft Word, Microsoft PowerPoint, Excel, as well as internet applications including e-mail, world-wide web searches, electronic based research, web-page maintenance, and cloud-based/web-based research protocol management systems.
- Employee shall have knowledge or experience in human research protections and institutional review board (IRB) ethical and regulatory matters.
- Employee shall have a signed Non-Disclosure Agreement (NDA) in place with their company based on the potential access to confidential, proprietary, and/or sensitive information. NDA shall be provided to the Government Program Manager by start of performance.
- Experience working directly for a Department of Defense research regulatory affairs program office.
- Experience shall include the technical review and FDA research compliance review of non-clinical warfighter operational health and performance biosensing and human wearable bio-devices.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absence, compensation, and training.
If you need assistance or accommodation due to a disability, you may contact us at 1 833.743.7835. - 2 Days Ago
Food Regulatory Affairs Specialist
- Wyandot USA, LLC.
-
Marion, OH
FULL_TIME
- The Food Regulatory Affairs Specialist will be responsible for ensuring all claims made on packaging are met within regulatory requirements, as well as maintaining good standing with our regulatory bo...
- 7 Days Ago
Regulatory Affairs Specialist
- AirClean Systems
-
Brecksville, OH
FULL_TIME
- DescriptionSince 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT’s steady growth co...
- 1 Day Ago
Specialist I, Regulatory Affairs
- Enable Injections, Inc.
-
Cincinnati, OH
FULL_TIME
- Enable Injections develops and manufactures on-body delivery systems designed to improve the patient experience. QUALIFICATIONSRequiredBachelor's degree in biology, chemistry, engineering, or a relate...
- 12 Days Ago
Regulatory Affairs Specialist
- AtriCure, Inc.
-
Mason, OH
FULL_TIME
- AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons a...
- 9 Days Ago
Senior Regulatory Affairs Specialist
- Meridian Bioscience, Inc.
-
Cincinnati, OH
OTHER
- About Meridian Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to ...
- Just Posted
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Experis
-
Maplewood, MN
- Our client, is seeking a Regulatory Specialist to join their team. As a Regulatory Specialist, you will lead/ coordinate...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 6/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
-
- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/7/2024 12:00:00 AM
About Ohio
Ohio /oʊˈhaɪoʊ/ (listen) is a Midwestern state in the Great Lakes region of the United States. Of the fifty states, it is the 34th largest by area, the seventh most populous, and the tenth most densely populated. The state's capital and largest city is Columbus.
The state takes its name from the Ohio River, whose name in turn originated from the Seneca word ohiːyo', meaning "good river", "great river" or "large creek". Partitioned from the Northwest Territory, Ohio was the 17th state admitted to the Union on March 1, 1803, and the first under the Northwest Ordinance. Ohio is historically know...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$74,666 to $100,060
Most Popular Cities in Ohio for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
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