Regulatory Affairs Specialist Jobs in Pen Argyl, 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.
Compliance Analyst - Operations
- Hackettstown, NJ (22 miles from Pen Argyl, PA)
- 12 hours ago
- Hackettstown, NJ (22 miles from Pen Argyl, PA)
- 12 hours ago
Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New York State,...
Regulatory Compliance Specialist II
- Allentown, PA (19 miles from Pen Argyl, PA)
- 15 days ago
- Allentown, PA (19 miles from Pen Argyl, PA)
- 15 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...
Regulatory Compliance Specialist in Bethlehem,PA,US
- Bethlehem, PA (19 miles from Pen Argyl, PA)
- 30+ days ago
- Bethlehem, PA (19 miles from Pen Argyl, PA)
- 30+ days ago
Support third-party regulatory, customer, and internal audits by organizing, maintaining, and presenting necessary documentation....
- Easton, PA (7 miles from Pen Argyl, PA)
- 90+ days ago
- Easton, PA (7 miles from Pen Argyl, PA)
- 90+ days ago
Scope: The Senior Trade Compliance Analyst is responsible for supporting and assisting export and/or import activities with oversight and direction from the Global Trade Compliance Manager....
Demographic Data for Pen Argyl, PA
Moving to Pen Argyl, PA? Find some basic demographic data about Pen Argyl, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Pen Argyl, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Pen Argyl, PA 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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