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Regulatory Affairs Data Specialist Jobs

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
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.
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
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 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
Regulatory Affairs Specialist Jobs
By Medtronic At , Woburn
Assist in keeping company informed of regulatory requirements in the International Regions.
Host meetings with relevant R&D, Quality, Manufacturing facility, Marketing and Cross Functional Teams as needed to support global registration requirements.
Bachelor's degree with 2 years of regulatory affairs experience
An advanced degree with 0 years of regulatory affairs experience
3+ years of medical device regulatory affairs experience
Experience with international submissions and experience with the FDA
Regulatory Affairs Specialist Jobs
By AM Logic Corporation At , Edison, 08820, Nj
Communicate submission requirements to product development and process improvement teams.
Develop detailed strategies and perform activities necessary to secure domestic and foreign regulatory clearance, approval, and registration of products.
Maintain annual facility registrations and product listings as appropriate.
Develop competitive regulatory strategies and execute on filing submissions to regulatory authorities and ensure the maintenance of regulatory files.
Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.
Requires Bachelors in Pharmacy, Regulatory Affairs, any Scientific Degree, or related.
Regulatory Affairs Specialist Ii
By Thermo Fisher Scientific At , Fremont, 94555, Ca
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
Perform other related duties and responsibilities, on occasion, as assigned.
Excellent communication skills and attention to detail.
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
Must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations. Excellent oral presentation skills.
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
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.

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