Register
Recruit Create CV

Regulatory Affairs Data Specialist Jobs

Specialist I, Regulatory Affairs - Medical Device
By Werfen At , San Diego, 92121, Ca $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.
Global Regulatory Affairs Specialist
By ICON At , , Ga
An ambitious regulatory professional with experience of working as Regulatory Specialist across multiple regions. Additional requirements include:
Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy.
Become part of the supportive and extremely knowledgeable regulatory professional team who are collaborative.
Prior experience in the preparation of RA and Central IEC submissions for Clinical Trial Applications ideally across regions.
What we can offer you:
Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission packages.
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 Cmc Specialist (Remote)
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.
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.
Vp, Regulatory Data & Controls
By Investment Bank At New York City Metropolitan Area, United States
Collaborate across multiple teams to translate regulatory compliance requirements into implementable data controls
Lucrative base salary, bonus, and benefits
lucrative base salary, bonus, and benefits
Drive strategic initiatives for regulatory reporting data governance and data quality controls.
Familiarity with the reporting process from end to end, especially how data are consumed by various regulatory reports (ex. FR Y-9C)
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 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

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