Regulatory Affairs Specialist Jobs in Hatfield, 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 (19 miles from Hatfield, PA)
- 2 days ago
- Berwyn, PA (19 miles from Hatfield, PA)
- 2 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...
Governance, Risk, and Compliance Analyst, Specialist
- Malvern, PA (21 miles from Hatfield, PA)
- 6 days ago
- Malvern, PA (21 miles from Hatfield, 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...
Sr. Specialist, Regulatory Affairs
- North Wales, PA (6 miles from Hatfield, PA)
- 6 days ago
- North Wales, PA (6 miles from Hatfield, PA)
- 6 days ago
regulations, preferred Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage...
- Wayne, PA (16 miles from Hatfield, PA)
- 6 days ago
- Wayne, PA (16 miles from Hatfield, 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 WorkRegulatory Compliance Specialist II
- Allentown, PA (24 miles from Hatfield, PA)
- 7 days ago
- Allentown, PA (24 miles from Hatfield, PA)
- 7 days ago
Regulatory Compliance Specialist II Allentown, Pennsylvania, United States | Posted: 6/24/2025 Indotronix is an Equal Opportunity Employer Let Us Do the Heavy Lifting! Upload your resume and we'll...
Compliance Analyst- HMDA Originations
- Fort Washington, PA (11 miles from Hatfield, PA)
- 7 days ago
- Fort Washington, PA (11 miles from Hatfield, PA)
- 7 days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Regulatory Compliance Specialist II
- Allentown, PA (24 miles from Hatfield, PA)
- 8 days ago
- Allentown, PA (24 miles from Hatfield, PA)
- 8 days ago
Position: Regulatory Program Specialist Location: Allentown, PA (Hybrid) 2 years contract Job Responsibilities Directs the implementation and communication of energy conservation programs and...
- Newtown Square, PA (22 miles from Hatfield, PA)
- 8 days ago
- Newtown Square, PA (22 miles from Hatfield, PA)
- 8 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 (21 miles from Hatfield, PA)
- 9 days ago
- Malvern, PA (21 miles from Hatfield, PA)
- 9 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 (22 miles from Hatfield, PA)
- 15 days ago
- Newtown Square, PA (22 miles from Hatfield, 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 Regulatory Compliance Analyst
- Philadelphia, PA (24 miles from Hatfield, PA)
- 18 days ago
- Philadelphia, PA (24 miles from Hatfield, PA)
- 18 days ago
Provides legal guidance and counsel related to securities and banking regulatory matters. Staff maintains relationships with regulatory bodies and agencies and has significant expertise in...
Info Security Compliance Analyst
- Philadelphia, PA (24 miles from Hatfield, PA)
- 19 days ago
- Philadelphia, PA (24 miles from Hatfield, PA)
- 19 days ago
Info Security Compliance Analyst Info Security Compliance Analyst Company: Boston College Job Location: Chestnut Hill, 02467 Category: Assessment, Accreditation, and Compliance Type: Full-Time...
Remote WorkCredentialing Compliance Analyst - Hybrid
- Philadelphia, PA (24 miles from Hatfield, PA)
- 19 days ago
- Philadelphia, PA (24 miles from Hatfield, PA)
- 19 days ago
The Credentialing Compliance Analyst responsibilities include developing, implementing, and facilitating the regulatory and accreditation credentialing investigation process. Identifying and...
Remote WorkSr Compliance Analyst- Originations
- Fort Washington, PA (11 miles from Hatfield, PA)
- 20 days ago
- Fort Washington, PA (11 miles from Hatfield, PA)
- 20 days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Trade Compliance Analyst (Contract Role)
- Colmar, PA (2 miles from Hatfield, PA)
- 21 days ago
- Colmar, PA (2 miles from Hatfield, PA)
- 21 days ago
Dorman was founded on the belief that people should have greater freedom to fix motor vehicles. For over 100 years, we have been driving new solutions, releasing tens of thousands of aftermarket...
Demographic Data for Hatfield, PA
Moving to Hatfield, PA? Find some basic demographic data about Hatfield, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hatfield, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hatfield, 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
- ICH Guidelines
- 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
- Writing Skills
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- 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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