Regulatory Affairs Specialist Jobs in Boyertown, 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.
Global Senior Governance, Risk, and Compliance Analyst (King Of Prussia, PA, US, 19406)
- King of Prussia, PA (23 miles from Boyertown, PA)
- 3 days ago
- King of Prussia, PA (23 miles from Boyertown, PA)
- 3 days ago
Requistion Number: 26210 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nation's premiere propane company, serving over 1.5 million residential,...
Sr SOX Compliance Analyst - Business Process (King Of Prussia, PA, US, 19406)
- King of Prussia, PA (23 miles from Boyertown, PA)
- 3 days ago
- King of Prussia, PA (23 miles from Boyertown, PA)
- 3 days ago
Requistion Number: 26259 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nation's premiere propane company, serving over 1.5 million residential,...
Governance, Risk, and Compliance Analyst, Specialist
- Malvern, PA (22 miles from Boyertown, PA)
- 14 days ago
- Malvern, PA (22 miles from Boyertown, PA)
- 14 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...
Regulatory Compliance Specialist II
- Allentown, PA (21 miles from Boyertown, PA)
- 15 days ago
- Allentown, PA (21 miles from Boyertown, 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...
Corporate Governance & Compliance Analyst
- Reading, PA (13 miles from Boyertown, PA)
- 29 days ago
- Reading, PA (13 miles from Boyertown, PA)
- 29 days ago
Corporate Governance & Compliance Analyst Enersys - 3.1 Reading, PA Job Details Estimated: $67.5K - $85.5K a year 15 hours ago Qualifications Microsoft Excel Mid-level Microsoft Office Project...
Remote WorkCorporate Legal Governance & Compliance Analyst
- Reading, PA (13 miles from Boyertown, PA)
- 29 days ago
- Reading, PA (13 miles from Boyertown, PA)
- 29 days ago
Corporate Legal Governance & Compliance Analyst Enersys - 3.1 Reading, PA Job Details Estimated: $67.5K - $85.5K a year 1 day ago Qualifications Microsoft Excel Mid-level Microsoft Office Project...
Remote WorkRegulatory Compliance Specialist in Bethlehem,PA,US
- Bethlehem, PA (23 miles from Boyertown, PA)
- 30+ days ago
- Bethlehem, PA (23 miles from Boyertown, PA)
- 30+ days ago
Support third-party regulatory, customer, and internal audits by organizing, maintaining, and presenting necessary documentation....
Senior Specialist, Regulatory Affairs - Medical Device
- Exton, PA (21 miles from Boyertown, PA)
- 30+ days ago
- Exton, PA (21 miles from Boyertown, 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...
Senior Specialist, Regulatory Affairs
- Exton, PA (21 miles from Boyertown, PA)
- 45+ days ago
- Exton, PA (21 miles from Boyertown, 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 Boyertown, PA)
- 60+ days ago
- King of Prussia, PA (23 miles from Boyertown, PA)
- 60+ 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 Boyertown, PA)
- 60+ days ago
- King of Prussia, PA (23 miles from Boyertown, PA)
- 60+ 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,...
Sr Regulatory Affairs Specialist
- Audubon, PA (21 miles from Boyertown, PA)
- 90+ days ago
- Audubon, PA (21 miles from Boyertown, PA)
- 90+ days ago
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these...
Demographic Data for Boyertown, PA
Moving to Boyertown, PA? Find some basic demographic data about Boyertown, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Boyertown, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Boyertown, 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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