Regulatory Affairs Specialist Jobs in Kennett Square, PA
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.
IT COMPLIANCE ANALYST - Hybrid
- Berwyn, PA (17 miles from Kennett Square, PA)
- 3 days ago
- Berwyn, PA (17 miles from Kennett Square, PA)
- 3 days ago
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview The ideal candidate for the...
Portfolio Compliance Analyst - Delaware
- Wilmington, DE (14 miles from Kennett Square, PA)
- 6 days ago
- Wilmington, DE (14 miles from Kennett Square, PA)
- 6 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...
Governance, Risk, and Compliance Analyst, Specialist
- Malvern, PA (15 miles from Kennett Square, PA)
- 6 days ago
- Malvern, PA (15 miles from Kennett Square, PA)
- 6 days ago
Global Risk and Security (GR&S) at Vanguard enables business strategy, protects client and Vanguard interests (e.g., assets and data), and stewards a strong risk culture. Our teams leverage...
- Wayne, PA (21 miles from Kennett Square, PA)
- 6 days ago
- Wayne, PA (21 miles from Kennett Square, PA)
- 6 days ago
Please read - the annual compensation range for this position is $100-105K. Open to fully remote candidates in the Eastern Time Zone or hybrid near the Greater Philadelphia area. Interested in a...
Remote Work- Newtown Square, PA (16 miles from Kennett Square, PA)
- 9 days ago
- Newtown Square, PA (16 miles from Kennett Square, PA)
- 9 days ago
Role Overview This position sits within the Compliance Department. It will have a focus on communication, engagement and strategy. Heavy SharePoint usage and involvement with the budget and...
Business Unit & Product Compliance Analyst, Specialist
- Malvern, PA (15 miles from Kennett Square, PA)
- 10 days ago
- Malvern, PA (15 miles from Kennett Square, PA)
- 10 days ago
Job Description Regulatory Engagement & Tracking: Maintain and track regulatory inquiries, submissions, and correspondence, in an organized and consistent manner to ensure timely, accurate...
SAP CSA iXp Intern - Information Security Compliance Analyst
- Newtown Square, PA (16 miles from Kennett Square, PA)
- 15 days ago
- Newtown Square, PA (16 miles from Kennett Square, PA)
- 15 days ago
We help the world run better At SAP, we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How? We focus every...
Senior Specialist, Regulatory Affairs - Medical Device
- Exton, PA (12 miles from Kennett Square, PA)
- 30+ days ago
- Exton, PA (12 miles from Kennett Square, PA)
- 30+ days ago
, Skills and Abilities Advanced knowledge of ISO 13485 Attention to detail with planning, time management and organizational skills Regulatory compliance competency including Quality Systems Experience...
Regulatory Compliance Specialist
- King of Prussia, PA (23 miles from Kennett Square, PA)
- 30+ days ago
- King of Prussia, PA (23 miles from Kennett Square, PA)
- 30+ days ago
Company Description Clean Earth is a leading provider of environmental services in the United States providing remediation, disposal, recycling, and beneficial reuse solutions for hazardous and...
Senior Specialist, Regulatory Affairs
- Exton, PA (12 miles from Kennett Square, PA)
- 45+ days ago
- Exton, PA (12 miles from Kennett Square, PA)
- 45+ days ago
, Skills and Abilities Advanced knowledge of ISO 13485 Attention to detail with planning, time management and organizational skills Regulatory compliance competency including Quality Systems Experience...
Sr SOX Compliance Analyst - Business Process
- King of Prussia, PA (23 miles from Kennett Square, PA)
- 45+ days ago
- King of Prussia, PA (23 miles from Kennett Square, PA)
- 45+ days ago
Requistion Number: 26259 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nations premiere propane company, serving over 1.5 million residential,...
Global Senior Governance, Risk, and Compliance Analyst
- King of Prussia, PA (23 miles from Kennett Square, PA)
- 45+ days ago
- King of Prussia, PA (23 miles from Kennett Square, PA)
- 45+ days ago
Requistion Number: 26210 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nations premiere propane company, serving over 1.5 million residential,...
Regulatory Affairs Specialist 4
- Newark, DE (17 miles from Kennett Square, PA)
- 60+ days ago
- Newark, DE (17 miles from Kennett Square, PA)
- 60+ 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...
- Wilmington, DE (14 miles from Kennett Square, PA)
- 90+ days ago
- Wilmington, DE (14 miles from Kennett Square, PA)
- 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 Kennett Square, PA
Moving to Kennett Square, PA? Find some basic demographic data about Kennett Square, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Kennett Square, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Kennett Square, PA 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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