Regulatory Affairs Specialist Jobs in Ralston, NE
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.
- Omaha, NE (7 miles from Ralston, NE)
- 13 days ago
- Omaha, NE (7 miles from Ralston, NE)
- 13 days ago
Axos Clearing LLC Target Range: $68,640.00/Yr. - $80,000.00/Yr. Actual starting pay will vary based on factors including, but not limited to, geographic location, experience, skills, specialty,...
Product & Regulatory Compliance Analyst - Remote
- Omaha, NE (7 miles from Ralston, NE)
- 15 days ago
- Omaha, NE (7 miles from Ralston, NE)
- 15 days ago
We're seeking a Product & Regulatory Compliance Analyst to help us keep our products strong, trustworthy, and ready for market. You'll make a meaningful impact by ensuring our customers receive...
Remote Work- Omaha, NE (7 miles from Ralston, NE)
- 30+ days ago
- Omaha, NE (7 miles from Ralston, NE)
- 30+ days ago
Company: NICO National Indemnity Company Want to work for a company with unparalleled financial strength and stability that offers large company benefits with an exciting, friendly, and small...
Information Security Compliance Analyst
- Omaha, NE (7 miles from Ralston, NE)
- 30+ days ago
- Omaha, NE (7 miles from Ralston, NE)
- 30+ days ago
Position Summary This is a FULL-TIME, onsite position located in Omaha, NE. Active SECRET government security clearance required at the time of application. NCC is seeking an Information Security...
Demographic Data for Ralston, NE
Moving to Ralston, NE? Find some basic demographic data about Ralston, NE below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Ralston, NE
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Ralston, NE offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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