Regulatory Affairs Specialist Jobs in Bear, DE
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.
Portfolio Compliance Analyst - Delaware
- Wilmington, DE (13 miles from Bear, DE)
- 14 days ago
- Wilmington, DE (13 miles from Bear, DE)
- 14 days ago
About this role Portfolio Compliance Group Implementation Team Have a passion for the investment industry and an interest in programming? Are you a compliance professional who is looking for a...
Regulatory Affairs Specialist 4
- Newark, DE (1 mile from Bear, DE)
- 90+ days ago
- Newark, DE (1 mile from Bear, DE)
- 90+ days ago
The Regulatory Affairs Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local...
Demographic Data for Bear, DE
Moving to Bear, DE? Find some basic demographic data about Bear, DE below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Bear, DE
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Bear, DE offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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