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Regulatory Affairs Jobs in Austin, 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
Director Of Compliance & Regulatory Affairs (Remote - United States)
By Season Health At Austin, TX, United States
Develop, build, manage and oversee the organization’s compliance program, aligned to CMS/HHS guidance, and privacy program
Develop internal guidelines, toolkits, and packaged knowledge for the business on relevant regulatory & compliance issues
Significant prior experience managing a compliance program aligned to CMS/HHS guidelines is required
Prior experience directly advising Product and Marketing teams strongly preferred
This is a remote role, but you must reside in the US
Exceptional written and verbal communication skills, understanding your audience and calibrating your messaging appropriately
Director- Iso Regulatory Affairs
By Jupiter Power At Austin, TX, United States
5-7 years of experience in regulatory affairs, policy, trade compliance, strategy or business development in the power market industry
Experience in PJM, MISO or NYISO power markets
Experience in managing external consultants and deriving/approving external scopes of work
Experience representing power generation in ISO/RTOs
Extensive work experience beyond the 5-year minimum.
Lead ISO/RTO Regulatory Affairs Activities for FERC jurisdictional electricity markets, including formulation of internal policy goals and external representation
Regulatory Affairs Manager Jobs
By Brunel At Dallas-Fort Worth Metroplex, United States
5+ years of progressive regualtory affairs experience
Submissions experience - EU and International markets
Oversee the regualtory function for full product portfolio, managing a team, department and budget
Coordinate regulatory submissions in US and OUS markets
Provide regulatory input/support for audits
Regulatory strategy for product development
Director Of Regulatory Affairs
By Tabseer | تبصير At Dallas, TX, United States
-Thorough knowledge of relevant regulatory laws, guidelines, and industry standards in Products Certification and Inspection Activities.
-Excellent communication and negotiation skills to articulate regulatory requirements and advocate on behalf of Tabseer.
-Good relationship with top level of Saudi Regulators’ Management Team.
Job Title: Regulatory Affairs Manager
-Clarify any ambiguous regulatory points or requirements by engaging with regulators and coordinating with internal teams.
-Stay informed about changes in regulatory landscape and assess their impact on Tabseer's certification and inspection operations.
Regulatory Affairs Associate Jobs
By Fred Hutchinson Cancer Center At , Seattle, 98109 $70,817 - $106,225 a year
Skilled in the use of clinical trials and electronic document management systems
Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.
Assist with sponsor monitoring visits remotely and onsite as needed.
Perform other responsibilities as assigned.
Bachelor’s Degree in a related field or equivalent experience
Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
Director Of Regulatory Affairs
By Sterling-Hoffman Life Sciences At Richardson, TX, United States
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the nutraceuticals industry is strongly preferred
4) Preference will be given to candidates with recent experience in regulatory affairs
4) Help the Regulatory Affairs Team apply complex regulatory concepts to projects in an easy-to-understand manner
5) Understand the interrelationship between labeling, artwork, and product regulations
8) Maintain regulatory records and files
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.)
Clinical Regulatory Affairs Associate
By Compliance Group Inc At Plano, TX, United States
EDUCATION AND EXPERIENCE YOU’LL BRING
Strong organizational and follow-up skills, as well as attention to detail.
Experience writing clear and concise technical documents.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
May interface directly with FDA and other regulatory agencies.
Work with cross-functional team to support product release process.
Regulatory Affairs Associate Jobs
By Mindlance At Plano, TX, United States
Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)
Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA.
Review regulatory documents to assure FDA requirements are met and are ready for submission
With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements.
Needs to be able to organize and prioritize tasks and work independent of manager.
With more complex tasks/submissions, work with the manager to accomplish goals/tasks.
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 S Jobs
By Whiteforce At , Atlanta, Ga

Employment Information Industry Regulatory Affa Job level Salary - Experience - Pay-Type Close-date JOB-ID JB-22064 Location Atlanta ...