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Regulatory Affairs Data Specialist Jobs in Texas

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
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 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.)
Regulatory Affairs Specialist I
By Abbott At Dallas, 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.)
Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Abbott Park, Il
Contribute to the development and functioning of the crisis/ issue management program
Determine and communicate submission and approval requirements
Participate in risk-benefit analysis for regulatory compliance
Assist compliance with product post marketing approval requirements
Submit and review change controls to determine the level of change and consequent submission requirements
Assist in SOP development and review
Regulatory Affairs Specialist - Cv Research
By Mayo Clinic At , Rochester, 55905, Mn $30.25 - $45.41 an hour

Affirmative Action and Equal Opportunity Employer

Senior Regulatory Affairs Specialist (Open To Remote)
By Cargill At , Wayzata, Mn $95,000 - $115,000 a year

Want to build a stronger, more sustainable future and cultivate your career? Join Cargill's global team of 160,000 employees who use new technologies, dynamic insights and over 157 years of experience ...

Sr Regulatory Affairs Specialist
By Intuitive Surgical At , Sunnyvale, Ca $107,600 - $182,100 a year
Extensive working knowledge of design controls, risk management, verification and validation, and product labeling requirements/documentation
Required Knowledge, Skills and Experience
Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
Experience with complex products including Software as a Medical Device is a plus
Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
Regulatory Affairs Specialist Jobs
By Baylor College of Medicine At , Houston, 77030, Tx
Prior experience with data management of research and regulated protocols
Excellent project management and organizational skills
Proficiency with document control and reference management software
Four years of relevant experience.
Bachelor’s degree in a health science discipline, no experience required with Bachelor’s degree
Basic understanding and application of principles, concepts, practices and standards, and knowledge of industry practices
Regulatory Affairs Specialist Jobs
By Endologix At , Irvine, 92618, Ca $65,000 - $95,000 a year
Maintains up-to-date knowledge on domestic and international regulatory requirements, and effectively communicates requirements to project teams and management.
Perform other duties as assigned by Regulatory Affairs Management
Supports RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
Good interpersonal skills including ability to interact with high degree of diplomacy.
Knowledge of global medical device regulations.
Experience in developing and communicating global regulatory strategies.
Regulatory Affairs Specialist Jobs
By Mayo Clinic At , Rochester, 55901, Mn $62,920 - $94,453 a year

Affirmative Action and Equal Opportunity Employer

Regulatory Affairs Specialist (Eumdr) $90K Base (100% Remote)
By CyberCoders At Houston, TX, 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 Jobs
By Sally Beauty Holdings At , Denton, Tx
0-3 years of related industry experience. Experience in US and international cosmetic regulatory issues.
10% Product registration/notification in all applicable markets, e.g., Canada, Chile, Columbia, Peru etc.
10% Regulatory due diligence of branded products. Review product labels and work with vendors for compliance.
Bachelors degree in Chemistry, Biochemistry, or related fields.
Nature and Extent of Direct or Indirect Controls Exercised by the Supervisor
The amount of discretion or freedom this position has
Regulatory Affairs Scientist Jobs
By Procter & Gamble At , Boston, 02199, Ma $85,000 - $115,000 a year
Independent regulatory manager, responsible for ensuring compliance of multiple product forms with North America.
Guides and influences project direction and solves significant technical problems by leveraging scientific skills.
Previous regulatory experience is favorable but not required.
Critically evaluates regulatory laws, develops regulatory strategies, identifies issues/risks and develop proactive plans to address.
Develop effective regulatory strategy for initiatives/projects by understanding the North America Regulatory framework impacting the Shave Care business.
Works x-functionally within R&D and Product Supply to incorporate regulatory compliance.

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