Regulatory Affairs Specialist Jobs in Austin, TX
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
NERC Compliance Analyst - Operations & Planning (Onsite)
- Austin, TX
- 2 days ago
- Austin, TX
- 2 days ago
13861- NERC Compliance Analyst - Operations & Planning (Onsite)- Austin, TX Start Date : ASAP Type: Temporary Project Estimated Duration : 12 months with possible extensions Work Setting: 100% of...
TDI-Compliance Analyst I (00049648) Job Description TDI-Compliance Analyst I (00049648) Organization: TEXAS DEPARTMENT OF INSURANCE Primary Location: Texas-Austin Work Locations: Aus Barbara...
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkAbout Marvell Marvell's semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier...
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Position Summary The Property Compliance Analyst will complete a variety of assignments related to tenant file compliance with Section 42, Section 8 or other Government Housing Programs with a...
Your Future Evolves Here Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
AML Analyst/Compliance Analyst Location: Austin TX (Hybrid role- 3 day onsite 2 days work from home) Duration: 6+ Months (possibility of extension) Pay Range $35-37/hr. You will collaborate with...
RWE Clean Energy, LLC To start as soon as possible, full time, permanent This position supports the RWE Clean Energy (RWECE) Internal Compliance Program established to maintain compliance with...
Regulatory & Market Compliance Analyst Sr Apply now Job No: 499552 FT/PT: Full-time Regular/Project/Seasonal: Regular Location: Austin, TX 78703 City: Austin State: Texas Categories: Government...
Follow all work/quality procedures to ensure quality system compliance and high-quality work....
Job Details Job Location : RIHS Austin Regional Office - Austin, TX Position Type : Full Time Salary Range : Undisclosed Description Primary Responsibilities The primary responsibilities include...
Position Description AB is a leading global investment management firm that offers high-quality research and diversified investment services to institutional clients, individuals, and private...
. • Follow all work/quality procedures to ensure quality system compliance and high-quality work. • Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management...
The Staff HR Compliance Analyst supports human resources related compliance projects and programs with cross-functional teams and focuses on improving and enhancing HR related policies, practices,...
Demographic Data for Austin, TX
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Austin, TX
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Austin, TX offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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