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Regulatory Affairs Internship 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- 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
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
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

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 ...

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 Associate Jobs
By Baylor College of Medicine At , Houston, 77030, Tx
Experience in regulatory affairs and/or clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.
Two years of relevant experience.
Ability to manage shifting priorities in short time frames.
Should have excellent oral and written communication skills.
Knowledge of medical/scientific terminology preferred.
Excellent organization skills; ability to multi-task.
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.