Regulatory Affairs Specialist Jobs in Bellevue, 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 (9 miles from Bellevue, NE)
- 14 days ago
- Omaha, NE (9 miles from Bellevue, NE)
- 14 days ago
Leads support efforts for the organization's human capital compliance duties, which include auditing employee files, reviewing HR processes and procedures, and proactively researching new...
Insurance Product Development Regulatory Compliance Analyst
- Omaha, NE (9 miles from Bellevue, NE)
- 15 days ago
- Omaha, NE (9 miles from Bellevue, NE)
- 15 days ago
Insurance Product Development Regulatory Compliance Analyst Argonaut Management Services, Inc life insurance, vision insurance, parental leave, paid time off, flex time, 401(k), profit sharing...
- Omaha, NE (9 miles from Bellevue, NE)
- 30+ days ago
- Omaha, NE (9 miles from Bellevue, NE)
- 30+ 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,...
Information Security Compliance Analyst
- Omaha, NE (9 miles from Bellevue, NE)
- 45+ days ago
- Omaha, NE (9 miles from Bellevue, NE)
- 45+ 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 Bellevue, NE
Moving to Bellevue, NE? Find some basic demographic data about Bellevue, NE below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Bellevue, NE
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Bellevue, NE offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Vendor Management
- Reimbursement
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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