Regulatory Affairs Specialist Jobs in Pennsylvania
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.
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch...
Remote WorkAre you excited by the opportunity to help shape something new, while being supported by a team of experienced peers? Vanguard's Cash+ Program is a first-of-its-kind offer, and we're looking for a...
Internal Reference Number: R1044888 Summary The Regulatory Compliance Specialist position is a part of Companion Life's Regulatory and Market Conduct Team within the Compliance Department. In this...
Company : Highmark Health Job Description : JOB SUMMARY This job works collaboratively to support of all risk and compliance assessment activities of Highmark Health across a broad range of...
Sr Product Stewardship & Regulatory Affairs Specialist Job
- Radnor, PA
- 4 days ago
- Radnor, PA
- 4 days ago
In conjunction with the Specialty Surfactants Business Unit (BU) for which the position is responsible, manage activities to assure compliance with legal and corporate product stewardship and...
Global Senior Governance, Risk, and Compliance Analyst (King Of Prussia, PA, US, 19406)
- King of Prussia, PA
- 6 days ago
- King of Prussia, PA
- 6 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
- 6 days ago
- King of Prussia, PA
- 6 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,...
Compliance Analyst (MS), Communication Surveillance
- West Mifflin, PA
- 9 days ago
- West Mifflin, PA
- 9 days ago
The Opportunity: In the role of the Compliance Analyst on our Managed Services team, you will be responsible for participating in and ensuring the successful execution of certain compliance...
Company : Highmark Health Job Description : JOB SUMMARY This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk Compliance...
eNGINE builds Technical Teams. We are a Solutions and Placement firm shaped by decades of interaction with Technical professionals. Our inspiration is continuous learning and engagement with the...
Senior Regulatory Affairs Specialist (Memphis, TN)
- Pittsburgh, PA
- 12 days ago
- Pittsburgh, PA
- 12 days ago
We're looking for a Regulatory Affairs Specialist to join our team and drive regulatory strategies for our cutting-edge products. If you're ready to make an impact, apply now!...
Job Description The Leave and Compliance Analyst is responsible for administering and managing employee leaves of absence, accommodation requests, worker's compensation claims, and ensuring...
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...
Experience: Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent Knowledge and application of 21 CFR 820 and ISO 13485 is required Knowledge and application...
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...
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Pennsylvania
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Pennsylvania 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
- Policy Development
- Bachelor's Degree
- Microsoft PowerPoint
- 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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