Regulatory Affairs Specialist Jobs in Newark, 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.
- Talleyville, DE (15 miles from Newark, DE)
- 2 days ago
- Talleyville, DE (15 miles from Newark, DE)
- 2 days ago
Nemours is seeking a Regulatory Affairs Specialist to join our team in Wilmington, DE....
Consumer Compliance Analyst (Banking)
- Wilmington, DE (12 miles from Newark, DE)
- 11 days ago
- Wilmington, DE (12 miles from Newark, DE)
- 11 days ago
Role: Consumer Compliance Analyst (Banking) Work Location: Mount Laurel, New Jersey; Wilmington, Delaware; and Charlotte, North Carolina for at least two days per week to be eligible for this...
- Wilmington, DE (12 miles from Newark, DE)
- 13 days ago
- Wilmington, DE (12 miles from Newark, DE)
- 13 days ago
Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA...
Consumer Compliance Analyst - Execution
- Wilmington, DE (12 miles from Newark, DE)
- 13 days ago
- Wilmington, DE (12 miles from Newark, DE)
- 13 days ago
Pay Range - $22-$25/hr on w2 Hybrid Location-based Roles - Candidates must be able to travel to work locations situated in Mount Laurel, New Jersey; Wilmington, Delaware; and Charlotte, North...
Senior Regulatory Affairs Specialist
- Wilmington, DE (12 miles from Newark, DE)
- 45+ days ago
- Wilmington, DE (12 miles from Newark, DE)
- 45+ days ago
Overview: This position is responsible for supervisory exam management, continuous monitoring, and may provide consultation and guidance to (1) senior management and (2) Regulatory Affairs...
- Wilmington, DE (12 miles from Newark, DE)
- 45+ days ago
- Wilmington, DE (12 miles from Newark, DE)
- 45+ days ago
Maintain internal control standards, including timely and thorough implementation of regulatory and internal audit requirements Participate in various ad hoc projects at a commensurate level of proficiency...
Demographic Data for Newark, DE
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Newark, DE
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Newark, DE offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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