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Regulatory Affairs Specialist II 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
Regulatory Affairs Associate Ii
By Integrated Resources, Inc ( IRI ) At United States
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• Manage the application and communication of all *** policies, procedures, and *** Way of Management.
• Effective personal time management.
LOCATION: Can be 100% Remote (or Hybrid/Plainsboro, NJ)
• Experience with submission work in VaultRim
• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER
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.
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
Irb Regulatory Coordinator Ii
By Fred Hutch At Seattle, WA, United States
Excellent time management skills and meet deadlines
Working knowledge of Microsoft Suite, SharePoint, Adobe Suite, Clinical Trials Management System.
Previous experience working with online/web-based platforms for clinical trial management systems
Manage the regulatory tracking and archive systems (e.g. SharePoint, Clinical Trials Management System, shared network drive, etc.).
A minimum two years of regulatory, human research protection or related experience in a research environment.
Previous work experience preparing and/or reviewing study start-up documents, including IRB documentation and research protocols.
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
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
Regulatory Affairs Specialist Cmc
By Viatris At , Remote $41,000 - $93,000 a year
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.
Key responsibilities for this role include:
The minimum qualifications for this role are:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Regulatory Associate Ii - Alliance Management (Remote)
By Tolmar Inc. At , Fort Collins, 80526 $75,000 - $85,000 a year
Knowledge of Database Management software.
Prepare and coordinate eCTD documentation for new marketing authorizations and lifecycle management submissions for RoW and Canada.
Assist Regulatory Management and other Regulatory Associates, as requested.
Maintain electronic document management system, as required, for responsible products.
The Regulatory Associate II, Alliance Management is expected to operate within the framework of Tolmar’s Core Values:
Working conditions are consistent with a normal office environment and/or remotely from home office.
Regulatory Affairs Specialist Jobs
By Verathon At , Bothell $89,500 - $138,600 a year
Manage regulatory release authorization process
Experience working in an FDA regulated company for medical device or pharma is preferred
2+ years’ experience in quality assurance or regulatory affairs is preferred
Previous experience in a position that required multi-department interactions
Able to manage time effectively
Develop and compile documentation in support of new registrations

Are you looking for an exciting opportunity to use your regulatory expertise to make a difference? We are looking for a Regulatory Affairs Specialist II to join our team and help us ensure compliance with all applicable regulations. You will be responsible for developing and maintaining regulatory strategies, preparing regulatory submissions, and providing regulatory guidance to internal stakeholders. If you are an experienced regulatory professional with a passion for making a positive impact, this could be the perfect job for you!

A Regulatory Affairs Specialist II is responsible for ensuring that a company’s products comply with all applicable laws, regulations, and standards. This includes researching and interpreting regulations, preparing and submitting regulatory documents, and providing guidance on regulatory compliance.

What is Regulatory Affairs Specialist II Skills Required?

• Knowledge of applicable laws, regulations, and standards
• Excellent research and analytical skills
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team
• Attention to detail
• Project management skills

What is Regulatory Affairs Specialist II Qualifications?

• Bachelor’s degree in a related field
• At least two years of experience in regulatory affairs
• Certification in regulatory affairs (preferred)

What is Regulatory Affairs Specialist II Knowledge?

• Knowledge of applicable laws, regulations, and standards
• Knowledge of regulatory requirements for product development and approval
• Knowledge of Good Manufacturing Practices (GMPs)
• Knowledge of medical device regulations

What is Regulatory Affairs Specialist II Experience?

• Experience in regulatory affairs
• Experience in medical device or pharmaceutical industry
• Experience in preparing and submitting regulatory documents

What is Regulatory Affairs Specialist II Responsibilities?

• Research and interpret applicable laws, regulations, and standards
• Prepare and submit regulatory documents
• Provide guidance on regulatory compliance
• Monitor regulatory changes and update internal procedures