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Regulatory Affairs Data Specialist Jobs in Union, Arkansas

Regulatory Affairs Specialist Cmc
By Viatris At United States
Assist departmental management in providing regulatory guidance to other departments (QA, QC, Manufacturing, Technical Services, etc.) for planned changes.
Position functions autonomously and consults with departmental management on an as-needed basis.
Position is remote, but expected to be a normal office situation occurring during typical US business hours.
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Regulatory Affairs Specialist - Medical Device
By Integrated Resources, Inc ( IRI ) At United States
Create and manage IVDR Technical Files.
It would be a plus if you also possess previous experience in: 510k author.
Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
Subject matter expertise in registration and commercialization of medical devices.
Global Regulatory Affairs Specialist
By ChromaDex At United States
Conduct cost/benefit/risk analyses and recommend options or proactive solutions to assure regulatory compliance of ChromaDex
Excellent oral and written communication skills
Excellent organizational skills and ability to multitask
Whip smart - we’re looking for candidates with a keen intellect who quickly learn what they don’t know
Adaptable – Able to apply yourself on a wide variety of tasks on a daily basis
Analytical - Can assess and leverage systems and processes to figure out more effective ways to get things done
Regulatory Affairs Specialist Us & Canada
By Valagro At United States
· Effective time management & project planning skills.
· Must have knowledge of U.S and European product submission and registration requirements.
· Ability to work independently, taking ownership of the management of processes, projects, and timelines.
· This is a remote position; the ideal candidate will work from home.
Permanent review of the labels in order to make them compliant with new regulatory requirements and chemical/physical parameters;
· 5 to 8 years hands-on submission experience including the developing and execution of regulatory strategies.
Regulatory Affairs Specialist Jobs
By Coda Search│Staffing At United States
Provides input to the Quality Education Unit to design Regulatory Specialist trainings and continuing education.
Explains regulations, policies and procedures to guide others on regulatory and compliance matters.
Assesses regulatory activities program wide and identify areas for improvement or that require correction and provides recommendations, as needed.
Initiates preparation for interim monitoring visits, internal audits and external audits/inspections for highly complex clinical research studies.
Monitors, interprets, applies, and communicates new and revised federal and state regulations, and local/institutional policies and guidance.
Maintains established departmental policies and procedures, objectives, quality assurance programs, safety, and compliance standards.
Regulatory Affairs Specialist Jobs
By Infobahn Softworld Inc At United States
Some project management experience is helpful.
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
Remote Position, however, Wisconsin/Neenah local to work hybrid remote/on-site is extremely desired .
• Regulatory experiences on Class I Medical Device, Consumer Products and Cosmetic Products.
10. Support the regulatory intelligence monitoring program by assessing changes in regulation and determining impact to K-C medical device products.
: Job Title: Contingent Support Regulatory Affairs
Ivdr Regulatory Affairs Specialist Ii
By Zing Recruiting At United States
Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.
Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
Bachelor’s degree (Master’s degree is a plus) with a minimum of 5 years of experience in a regulated industry.
Three-four years regulatory submissions work in domestic/international registrations and IVDR experience required.
Experience with IVD PMA submissions preferred.
Summary of responsibilities for this Regulatory Affairs Specialist II
Regulatory Affairs Specialist - Cmc
By Integrated Resources, Inc ( IRI ) At United States
: Technical Writing and Document Management
Schedule authoring, review, approval tasks and consensus meetings with stakeholders (SMEs, GRS CMC, management).
This is a fully remote role
Manage dossier content and agency questions delivery timelines aligned with global CMC submission timelines.
-Bachelors degree or equivalent in relevant discipline with a minimum of 2 years experience
-Proficiency in commonly used applications like Word/Excel is required. Documentum experience is preferred.
Regulatory & Clinical Affairs Specialist
By Compass Life Sciences At United States
Coordinating with administrative and research assistants and managers to coordinate
Experience authoring, assembling, and submitting IND applications
2+ years of experience in regulatory or clinical affairs.
Writing experience is required; examples to demonstrate successful writing preferred.
Ability to research, write and manipulate data through knowledgeable use of online technologies.
Author, assemble, and submit IND applications to FDA.
Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances
Reinsurance Prudential And Regulatory Affairs Specialist
By Insight Global At New York, NY, United States
-knowledge and experience in the insurance sector
-prior experience as an insurance supervisor
-prior experience as an actuary, insurance contract lawyer, or consultant in the financial services
-prior experience in coordinating projects involving a wide array of stakeholders.
-prior experience on ESG or cyber matters.
-ability to navigate and understand prudential regulation and supervisory guidance applicable to the insurance sector
Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121 $75,000 - $85,000 a year
Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management.
Must possess a strong willingness to comply with regulations and procedures and provide transparency to management regarding all work related issues.
Experience and knowledge regarding global premarket clearance activities preferred.
Experience and knowledge regarding global post market activities preferred.
Responsibilities may include pre-market and/or post-market as defined by the company.
Assist in tracking standards, regulations and all applicable requirements.
Regulatory Affairs Intelligence Specialist
By Abbott Laboratories At , Plymouth $56,700 - $113,300 a year
Support all company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
Experience in program management a plus
Experience with document management systems a plus
EDUCATION AND EXPERIENCE YOU’LL BRING
Performs other related duties and responsibilities, on occasion, as assigned
Strong verbal and written communication skills · Strong attention to detail and organizational skills
Senior Regulatory Affairs Specialist
By NuVasive, Inc. At , San Diego $96,000 - $160,000 a year
Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
Knowledge of US FDA Quality System Requirements (QSR), and ISO 13485.
This position is remote eligible, but we prefer candidates commutable to our San Diego, CA office
Ability to determine, communicate and make recommendations for submission and approval requirements to others
Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs
Understanding of regulatory terminology, pre-market submission types, and requirements
Regulatory Affairs Specialist Jobs
By ICON At , Farmingdale, 11735
Experience in regulatory requirements in clinical phase of biologics drug development is a plus
Excellent written and oral communication skills
Strong technical writing and editing skills
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
Initiate regulatory submission when required and support ICON team with Regulatory Inspections
Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Des Plaines $71,300 - $142,700 a year
Interpret and apply regulatory requirements
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
Principles and requirements of promotion, advertising and labeling
Has broad knowledge of various technical alternatives and their potential impact on the business
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Regulatory Affairs Specialist Jobs
By Philips At , Cambridge
Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
Proficient knowledge of domestic and international standards
Experience in supporting international registrations and/or clinical investigations.
Experience with Software Medical Devices strongly preferred.
Proficient computer skills in Microsoft Office Suite
Read more about our employee benefits.
Specialist, Regulatory Affairs Jobs
By Edwards Lifesciences At ,
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
Solid knowledge of new product development systems
Ability to manage competing priorities in a fast paced environment

Are you looking for an exciting opportunity to use your regulatory affairs expertise to help shape the future of healthcare? We are looking for a Regulatory Affairs Data Specialist to join our team and help us ensure that our products meet all regulatory requirements. You will be responsible for collecting, analyzing, and interpreting data to ensure compliance with applicable regulations. If you are passionate about regulatory affairs and have a keen eye for detail, then this is the perfect job for you!

Overview Regulatory Affairs Data Specialists are responsible for ensuring that all regulatory data is accurate, up-to-date, and compliant with applicable regulations. They are responsible for managing the regulatory data of a company, including the collection, analysis, and reporting of data. They must also ensure that all regulatory data is properly documented and stored in a secure manner. Detailed Job Description Regulatory Affairs Data Specialists are responsible for managing the regulatory data of a company. This includes collecting, analyzing, and reporting data, as well as ensuring that all regulatory data is accurate, up-to-date, and compliant with applicable regulations. They must also ensure that all regulatory data is properly documented and stored in a secure manner. Regulatory Affairs Data Specialists must be able to interpret and analyze complex regulatory data and provide guidance to other departments on regulatory compliance. They must also be able to identify potential areas of risk and develop strategies to mitigate those risks. Job Skills Required
• Knowledge of applicable regulations and standards
• Excellent analytical and problem-solving skills
• Ability to interpret and analyze complex regulatory data
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to prioritize tasks and manage multiple projects
• Proficiency in Microsoft Office Suite
Job Qualifications
• Bachelor’s degree in a related field
• At least 3 years of experience in regulatory affairs
• Knowledge of applicable regulations and standards
• Experience in data analysis and reporting
Job Knowledge
• Knowledge of applicable regulations and standards
• Understanding of regulatory data management processes
• Knowledge of data analysis and reporting techniques
• Understanding of risk management principles
Job Experience
• At least 3 years of experience in regulatory affairs
• Experience in data analysis and reporting
• Experience in risk management
Job Responsibilities
• Collect, analyze, and report regulatory data
• Ensure that all regulatory data is accurate, up-to-date, and compliant with applicable regulations
• Document and store regulatory data in a secure manner
• Interpret and analyze complex regulatory data
• Provide guidance to other departments on regulatory compliance
• Identify potential areas of risk and develop strategies to mitigate those risks
• Monitor changes in regulations and standards and update data accordingly