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
Regulatory Affairs Specialist (Remote)
By Zimmer Biomet At , Jacksonville, Fl $72,000 - $80,000 a year
A combination of education and experience may be considered
Evaluate risk of proposed regulatory strategies; may offer solutions
Writes and manages the development of package inserts
Strong writing, communication, and interpersonal skills
Knowledge of overall business environment, the orthopaedic industry, and the marketplace
Knowledge of FDA, EU, and other regulatory body regulations
Regulatory Affairs Specialist Jobs
By Escalate Sciences At Tampa, FL, United States
e. A Combination of background, education and experience can be considered.
Excellent communication skills (verbal and written) in English and preferable a second language (i.e. Spanish or Portuguese)
Identifies country specific Technical and/or Legal requirements and prepares documents to comply with country specific requirements.
Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
University/Bachelors degree or equivalent experience is required. Degree within atechnical related discipline is preferred.
Minimum of 4 years of related experience is preferred.
Regulatory Affairs Specialist(100% Remote) $95K
By CyberCoders At Miami, FL, United States
3-5+ years of professional OUS EUMDR Regulatory Affairs experience
Experience with Medical Device Reg Affairs for implantable
Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP
Full Benefits: Medical, Dental, Vision for employee and all dependents!
Bleeding Edge Technology = smart device to control pain relief!
Maintain licenses/registrations in existing territories
Regulatory Affairs Specialist (Eumdr) $90K Base (100% Remote)
By CyberCoders At Pompano Beach, FL, United States
3-5+ years of professional OUS EUMDR Regulatory Affairs experience
Experience with Medical Device Reg Affairs for implantable
Working knowledge of 21 CFR 820, ISO 13485, MDD, EU MDR, and MDSAP
Full Benefits: Medical, Dental, Vision for employee and all dependents!
Bleeding Edge Technology = smart device to control pain relief!
Maintain licenses/registrations in existing territories
Regulatory Specialist Jobs
By MBO Partners At Charlotte, NC, United States
Ensures the Quality Management System (QMS) is up to date per regulatory and sponsor requirements and maintains assessment/audit processes and documentation
Quality Management System/Regulatory Compliance Program
Regulatory certification from AAAHRP, SOCRA, PRIM&R or similar organizations
Has GCP training and follows GCP guidelines and other guidelines related to the conduct of human subject’s research
Develops and maintains departmental and study level SOPs in relation to clinical trials and according to FDA regulations and GCP guidance
Coordinates review, approval, and dissemination of policies with the internal compliance committee

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