Register
Recruit Create CV

Clinical Regulatory Affairs Specialist Jobs

Regulatory Affairs Specialist-Cleveland Jobs
By Biolink360 At , Pittsburgh, Pa
Extensive project management skills with the ability to work under deadlines, handle multiple priorities simultaneously, and work across multi-disciplinary teams.
3-7 years of Regulatory Affairs experience in the medical device or other area of life science industry.
FDA regulatory submission experience (Pre-Submission, 510Ks, De Novo, IDEs) and international submission experience a plus.
Do want the flexibility to work from home, with only being in the office 1-2 days/week?
Devise and execute with regulatory pathways and strategies, premarket FDA, and international regulatory submissions.
Serve as point person for external audits by regulatory and third party auditors.
Regulatory Affairs Specialist Jobs
By Medtronic At , Minneapolis, 55432, Mn
Strong organization and time management skills
Bachelor’s Degree with 2 years of regulatory affairs experience
An advanced degree with 0 years of regulatory affairs experience
2+ years of medical device regulatory affairs experience
Ability to effectively manage multiple projects and priorities
Excellent written and verbal communications skills
Regulatory Affairs Specialist 3 - Remote
By The Cooper Companies At , Trumbull, Ct $92,847 - $125,000 a year
Other Skills and Abilities: Knowledge and understanding of US, EU MDR and international medical device regulations.
Certificates, Licenses, Registrations: RAC certification is preferred.
Regulatory Experience: Minimum 4 years (Required).
510(k)/Technical File Experience: Minimum 4 years (Required).
Responsible for development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets.
Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions.
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.
Global Clinical & Regulatory Affairs Coordinator
By Omni Inclusive At United States
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Maintains organizational charts for both departments and maintain email distribution lists.
Supports expense reporting for leadership in GRA and GCA.
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
Clinical Affairs Jobs
By ProKatchers LLC At West Sacramento, CA, United States

The Clinical Affairs Scientist I will support the Clinical Affairs team during Microbiology antimicrobial susceptibility testing (AST) clinical trials. The incumbent performs testing as defined ...

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.
Senior Clinical Affairs Specialist (Remote - Usa)
By Bionano At United States
Support input from clinical studies to development teams for key requirements and sample management.
Effective communication, organization, and time management skills.
Summary, Primary Duties, Skills And Experience
Manage project portfolio across clinical sites in multiple clinical studies.
Manage the publication process for internal publications including writing text and gathering data/figures from other contributors.
Experience working with technical teams.
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.)

Are you looking for an exciting opportunity to join a dynamic team in the Clinical Regulatory Affairs field? We are looking for a Clinical Regulatory Affairs Specialist to join our team and help us ensure compliance with all applicable regulations. You will be responsible for preparing and submitting regulatory documents, tracking submissions, and providing regulatory support to internal and external stakeholders. If you are a detail-oriented professional with excellent communication and organizational skills, we want to hear from you!

Overview Clinical Regulatory Affairs Specialists are responsible for ensuring that clinical trials and other research activities comply with applicable regulations and standards. They work closely with clinical research teams to ensure that all regulatory requirements are met and that the research is conducted in an ethical and safe manner. Detailed Job Description Clinical Regulatory Affairs Specialists are responsible for ensuring that clinical trials and other research activities comply with applicable regulations and standards. They work closely with clinical research teams to ensure that all regulatory requirements are met and that the research is conducted in an ethical and safe manner. Clinical Regulatory Affairs Specialists are responsible for developing and maintaining regulatory strategies, preparing regulatory submissions, and providing regulatory guidance to clinical research teams. They also review and approve clinical trial protocols, analyze data from clinical trials, and provide regulatory advice to sponsors and investigators. Job Skills Required
• Knowledge of applicable regulations and standards
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong organizational and problem-solving skills
• Ability to manage multiple tasks and prioritize work
• Proficiency in Microsoft Office applications
Job Qualifications
• Bachelor’s degree in a related field
• At least two years of experience in clinical research or regulatory affairs
• Knowledge of applicable regulations and standards
• Understanding of clinical trial design and data analysis
• Ability to interpret and analyze clinical trial data
Job Knowledge
• Knowledge of applicable regulations and standards
• Understanding of clinical trial design and data analysis
• Knowledge of clinical research processes and procedures
• Knowledge of medical terminology
• Knowledge of Good Clinical Practice (GCP)
Job Experience
• At least two years of experience in clinical research or regulatory affairs
• Experience in preparing regulatory submissions
• Experience in reviewing and approving clinical trial protocols
• Experience in analyzing clinical trial data
Job Responsibilities
• Develop and maintain regulatory strategies
• Prepare regulatory submissions
• Provide regulatory guidance to clinical research teams
• Review and approve clinical trial protocols
• Analyze data from clinical trials
• Provide regulatory advice to sponsors and investigators
• Monitor clinical trials for compliance with applicable regulations and standards
• Ensure that research is conducted in an ethical and safe manner