Regulatory Affairs Specialist Jobs in Middletown, 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.
- Dover, DE (24 miles from Middletown, DE)
- 3 days ago
- Dover, DE (24 miles from Middletown, DE)
- 3 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote Work- Newark, DE (9 miles from Middletown, DE)
- 10 days ago
- Newark, DE (9 miles from Middletown, DE)
- 10 days ago
Analyst Compliance Analyst Newark, DE Compliance Analyst, Newark, DE AML COMPLIANCE ANALYST BCforward Newark, DE (Onsite) Contractor Job Details AML Compliance Analyst BCforward is currently...
- Dover, DE (24 miles from Middletown, DE)
- 11 days ago
- Dover, DE (24 miles from Middletown, DE)
- 11 days ago
Trade Compliance Analyst at Otsuka America Pharmaceutical Inc. in Dover, Delaware, United States Job Description Otsuka Pharmaceuticals - Trade Compliance Analyst Position Summary: + Provide...
- Wilmington, DE (18 miles from Middletown, DE)
- 16 days ago
- Wilmington, DE (18 miles from Middletown, DE)
- 16 days ago
At WSFS Bank, we empower our Associates to grow their careers, we guide our customers to secure their financial futures, and we actively support our Communities so they can fully thrive. Careers...
Niche Support Personnel - AML Compliance Analyst Basic (1-3 years)
- Newark, DE (9 miles from Middletown, DE)
- 17 days ago
- Newark, DE (9 miles from Middletown, DE)
- 17 days ago
ATR ID: ATR222186 Job Title: Niche Support Personnel - AML Compliance Analyst Basic (1-3 years) Job Level: Administrative Assistants Duration: 6 Months Location: Newark DE 19713 Email:...
Regulatory Affairs Specialist 4
- Newark, DE (9 miles from Middletown, DE)
- 18 days ago
- Newark, DE (9 miles from Middletown, DE)
- 18 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...
AML Compliance Analyst - 9Rh03FhoWtQn-3294
- Newark, DE (9 miles from Middletown, DE)
- 20 days ago
- Newark, DE (9 miles from Middletown, DE)
- 20 days ago
AML Compliance Analyst - 9Rh03FhoWtQn-3294 at Bucher & Christian Consulting, Inc. dba BCforward in Newark, Delaware, United States Job Description AML Compliance Analyst BCforward is currently...
- Newark, DE (9 miles from Middletown, DE)
- 22 days ago
- Newark, DE (9 miles from Middletown, DE)
- 22 days ago
Job Description As a SAR (Suspicious Activity Report) Compliance Investigator you will focus on meeting regulatory reporting requirements pertaining to the Bank Secrecy Act (BSA), Anti-Money...
Compliance Analyst I - Supervisory Control Policies and Procedures
- Greenville, DE (22 miles from Middletown, DE)
- 30+ days ago
- Greenville, DE (22 miles from Middletown, DE)
- 30+ days ago
Compliance Analyst I - Supervisory Control Policies and Procedures Location US-MO-Saint Louis ID 2025-7372 Category Compliance Position Type Regular | Full Time Work Type Onsite What You'll Be...
Regulatory Affairs Specialist, Senior
- Talleyville, DE (23 miles from Middletown, DE)
- 30+ days ago
- Talleyville, DE (23 miles from Middletown, DE)
- 30+ days ago
The Senior Regulatory Affairs Specialist is responsible for the successful implementation of regulatory goals and objectives....
Senior Regulatory Affairs Specialist
- Wilmington, DE (18 miles from Middletown, DE)
- 90+ days ago
- Wilmington, DE (18 miles from Middletown, DE)
- 90+ 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 (18 miles from Middletown, DE)
- 90+ days ago
- Wilmington, DE (18 miles from Middletown, DE)
- 90+ 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 Middletown, DE
Moving to Middletown, DE? Find some basic demographic data about Middletown, DE below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Middletown, DE
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Middletown, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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