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Regulatory Affairs Specialist II Jobs

Regulatory Affairs Specialist Jobs
By TekWissen ® At Chesterfield, MO, United States
Manage and submit monthly, biennial and annual renewals for assigned products.
BA/BS in a field of science, business, or a related degree plus 2 years of regulatory experience
Experience interpreting and complying with laws & regulations to support regulatory submissions/approvals.
Highly developed written and oral communication skills.
Experience successfully managing information in databases.
Ability to multitask and manage multiple projects in a fast-paced environment.
Regulatory Affairs Specialist Jobs
By Randstad Life Sciences US At Greater Chicago Area, United States
Serves system administrator for the client's US Regulatory electronic document management system
Helps to author, develop and/or collaborate on SOPs and Work Instructions for the Publishing and Electronic Document Management System
This person will serve as the primary publisher of US Regulatory submissions (Drug and Device)
Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time
Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types
Regulatory Affairs Ops Specialist I
Regulatory Affairs Specialist Jobs
By CitiStaffing At New York, NY, United States
Significant experience analyzing securities trading
Excellent computer/technology skills, particularly using systems to retrieve order and trade data and Microsoft Excel
Experience using Relativity and/or Global Relay Retrieval Platforms
Interface with regulators, including negotiating request limitations and response deadlines
Review and prepare documents for production to regulators and ensure timely and accurate responses to all regulatory inquiries
Analysis of requests, responses, and related documents for potential regulatory issues
Regulatory/Clinical Affairs Specialist
By GSI At Norcross, GA, United States
Maintain knowledge of current regulatory requirements and standards, and communicate changes to relevant stakeholders.
Knowledge of FDA regulations and international regulatory requirements.
Hybrid Work Environment: 3 days onsite, 2 days work from home
4+ years of experience in regulatory affairs within the medical industry.
Experience with registration and commercialization of medical devices.
Strong analytical, problem-solving, and decision-making skills.
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.
Regulatory Affairs Specialist Ii - Electrophysiology
By Abbott At Minnesota, United States
EDUCATION AND EXPERIENCE YOU’LL BRING
Performs other related duties and responsibilities, on occasion, as assigned.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Learn more about our benefits that add real value to your life to help you live fully:
Assists in the preparation of regulatory applications (including annual reports) to achieve departmental and organizational objectives.
Creates, reviews and approves engineering changes.
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
Senior Regulatory Affairs Specialist
By Navitas Life Sciences At Boston, MA, United States
8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.
Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.
Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.
Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.
Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & EU.
Associate Regulatory Affairs Specialist
By McKesson At Irving, TX, United States
Ability to use project management tools, including Smartsheet & SharePoint
Advanced MS Office (Word, PowerPoint, Excel) skills
Strong communication and collaboration skills
Demonstrated ability to manage multiple work streams
Prior experience in a compliance or regulatory function preferred
Typically, a minimum of 1-3 years of relevant experience. May have a degree or equivalent
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 I
By Abbott At Frisco, TX, United States
Bachelor’s degree or an equivalent combination of education and experience
Strong organizational and follow-up skills, as well as attention to detail.
Experience with medical device industry
Experience working in a broader enterprise/cross-division business unit model
Experience writing clear and concise technical documents.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Regulatory Affairs Specialist I
By Abbott At Dallas, TX, United States
Bachelor’s degree or an equivalent combination of education and experience
Strong organizational and follow-up skills, as well as attention to detail.
Experience with medical device industry
Experience working in a broader enterprise/cross-division business unit model
Experience writing clear and concise technical documents.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Regulatory Coordinator Ii (Remote Option)
By Cedars-Sinai At Beverly Hills, CA, United States
May lead assigned project improvement, optimization or enhancements with direct oversight and guidance provided by management team
Three (3) years minimum of directly related experience, or equivalent combination of education and experience.
Essential Job Duties And Responsibilities
Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
Regulatory Affairs Specialist; Labeling
By NewAgeSys, Inc At Princeton, NJ, United States
Creating and Maintaining SPLs for products in alignment with changing technical requirements.
Education: Bachelor's or Associate’s degree in a scientific discipline or English.
Req Title: Regulatory Affairs Specialist; Labeling
Client: A major pharma company
Work Address: 100 College Road West, 08540, Princeton, NJ
Supporting and prioritizing launch labeling components readiness for a successful launch.
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.
Hiring _ Senior Regulatory Affairs Specialist _ Remote
By Intellectt Inc At Lake Forest, IL, United States
Must have 3-5 years of experiences in Medical Device Regulatory Affairs
Have working knowledge in EU MDR
Have working knowledge in Regulatory Change Assessment in
Have working knowledge in US and EU medical device submissions
Have experience supporting internal and external inspections
Have experience with continuous improvement activities
Regulatory Affairs Specialist Jobs
By DOCS At All, MO, United States
Understanding IND process with a thorough knowledge of ICH and associated regulatory guidelines.
With a minimum of 2-4 years of regulatory affairs experience (TFDA/ IRB)
Excellent organizational skills and ability to prioritize and multi-task.
Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
Liaise with officials of Government agencies to facilitate evaluation processes and respond to requests for data in agreed timeline.
Perform TMF QC for regulatory activities, complete archiving requests/checks for regulatory submissions, and conduct the study/task-based trainings per needs
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 Specialist Jobs
By Real Staffing At Irvine, CA, United States
Support 510(k) reviews (if sufficient experience)
Excellent verbal and written communication skills
Experience in a collaborative cross-functional development environment
Experience with FDA’s ecopy submission template a plus
Assist with 510(k) IDE drafting/compilation
Assist with 510(k) ecopy and submission
Regulatory Affairs Specialist 2 Jobs
By Yale University At , New Haven, 06511, Ct
Preferred Education, Experience and Skills:
This position is working a remote schedule.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.
Experience in clinical research in an academic setting preferred. Experience in a Cancer Center setting preferred.
SOCRA/ACRP/RAPs (or equivalent) certification preferred.
Comprehensive Cancer Center - Clinical Trials Operations

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