Regulatory Affairs Specialist Jobs in Mckinney, 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.
- Frisco, TX (14 miles from Mckinney, TX)
- 2 days ago
- Frisco, TX (14 miles from Mckinney, TX)
- 2 days ago
Employee Applicant Privacy Notice Who we are: Shape a brighter financial future with us. Together with our members, we're changing the way people think about and interact with personal finance....
IT Risk and Compliance Analyst -Telecom Industry
- Frisco, TX (14 miles from Mckinney, TX)
- 2 days ago
- Frisco, TX (14 miles from Mckinney, TX)
- 2 days ago
Experience Required: 2-5 years of relevant experience in IT compliance, risk management, internal audit, or a related field....
Financial Crimes Compliance Analyst
- Richardson, TX (16 miles from Mckinney, TX)
- 11 days ago
- Richardson, TX (16 miles from Mckinney, TX)
- 11 days ago
Job Family : Investigator Travel Required : None Clearance Required : None What You Will Do : Perform reviews and investigations of alerts/cases and/or files in regard to Bank Secrecy Act (BSA),...
Senior Specialist, Regulatory Affairs and Compliance
- Allen, TX (6 miles from Mckinney, TX)
- 13 days ago
- Allen, TX (6 miles from Mckinney, TX)
- 13 days ago
. * Manages of executes a timely and effective internal audit program....
- Plano, TX (11 miles from Mckinney, TX)
- 19 days ago
- Plano, TX (11 miles from Mckinney, TX)
- 19 days ago
Overview Who we are Collaborative. Respectful. A place to dream and do. These are just a few words that describe what life is like at Toyota. As one of the worlds most admired brands, Toyota is...
- Addison, TX (20 miles from Mckinney, TX)
- 21 days ago
- Addison, TX (20 miles from Mckinney, TX)
- 21 days ago
Compliance Analyst - Driving Wage & Hour Compliance Through Data and Insight! The Compliance Analyst plays a pivotal role in ensuring organizational adherence to wage and hour regulations,...
- Farmers Branch, TX (24 miles from Mckinney, TX)
- 22 days ago
- Farmers Branch, TX (24 miles from Mckinney, TX)
- 22 days ago
The Company Neora, LLC has established a direct sales business model that provides our products to customers around the globe via thousands of direct sales Brand Partners, resulting in aggressive...
Regulatory Affairs Specialist III (Plano, TX)
- Plano, TX (11 miles from Mckinney, TX)
- 30+ days ago
- Plano, TX (11 miles from Mckinney, TX)
- 30+ days ago
In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR. Knowledge of ISO 14971 risk management for medical devices....
Audit Regulatory Affairs Specialist
- Richardson, TX (16 miles from Mckinney, TX)
- 30+ days ago
- Richardson, TX (16 miles from Mckinney, TX)
- 30+ days ago
Job Summary This position is responsible for conducting of regulatory exam and internal audits independently in accordance with Management direction....
Demographic Data for Mckinney, TX
Moving to Mckinney, TX? Find some basic demographic data about Mckinney, TX below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Mckinney, TX
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Mckinney, 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
- Financial Services
- Internal Control
- Reimbursement
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Written Communication
- Education Experience
- Investigation
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »