Regulatory/Clinical Affairs Specialist
By GSI At Sandy Springs, 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
Offering a highly competitive salary, comprehensive benefits package, and opportunities for growth and advancement within the company.
4 + years of experience in regulatory affairs within the medical device industry.
Experience with registration and commercialization of medical devices
Strong analytical, problem-solving, and decision-making skills.

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