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Regulatory Affairs Data Specialist Jobs in Iowa

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
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.
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 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 - Remote
By Corza Medical At , Remote
Superior Quality & Service. We deliver extraordinary experiences.
Development of tracking documents and follow-up to assure submissions are managed appropriately.
Minimum 2 years of experience in Regulatory Affairs in the medical device/drug industry.
Experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America.
Experience with medical device regulations (21 CFR, MDR, MDSAP, ISO 13485) and Biologics License Applications (21 CFR) preferred.
We do what is right.
Regulatory Affairs Specialist Jobs
By GC America Inc At , Remote
Consult with Product Management and Sales Administration on regulatory requirements for US and Canada
Work with product management to prepare, compile and maintain post market documentation
3 years of experience in regulatory affairs or quality assurance
Monitor regulatory environment in assigned markets(US, Canada) and communicate to global and domestic stakeholders
Prepare responses to regulatory authority requests by working with GCC regulatory affairs
Work with other GC Companies regulatory associates to support GCA sales and marketing needs associated with regulatory documentation
Specialist Data Maintenance Regulatory Affairs
By Viatris At , Remote $41,000 - $93,000 a year
Builds knowledge of electronic and paper publishing systems and tools and applies these tools to produce CMC change management outputs.
Key responsibilities for this role include:
The minimum qualifications for this role are:
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.
Quality Specialist - Rn (Regulatory Affairs)
By Stanford Health Care At , Palo Alto, 94304, Ca $64.52 - $85.49 an hour
Attends ongoing education as required for clinical database management.
Three (3) years of progressively responsible and directly related work experience
SHC Commitment to Providing an Exceptional Patient & Family Experience
You will do this by executing against our three experience pillars, from the patient and family’s perspective:
Conducts comprehensive quality and patient safety studies, assessments, and evaluations of specific clinical activities for effectiveness
Conducts work independently and escalates system issues as necessary.
Regulatory Affairs Sr Specialist (Remote)
By Zimmer Biomet At , Remote $98,700 - $122,500 a year

Requisition Number AMER27218 Employment Type Full-time Location Virtual Office - Indiana Job Summary Zimmer Biomet is a global medical technology leader. Our team members are ...

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