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.
Our mission is to make higher education accessible and affordable for everyone.** We empower students with financial support and supercharge their ability to pay down their debt, so they can get...
Remote WorkEvery day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. Our...
Lead the Fight Against Financial Crime at Vanguard In this crucial role, you'll be at the forefront of Vanguard's Anti-Money Laundering and Compliance Operations. You'll identify and report...
Supports day-to-day Know Your Customer (KYC) operations with a specific focus screening new clients and evaluating their potential risk to money laundering activities and illicit financing....
Business Intelligence and Compliance Analyst- REMOTE
- Harrisburg, PA
- 7 days ago
- Harrisburg, PA
- 7 days ago
Job Seekers can review the Job Applicant Privacy Policy by clicking here ( ). Job Description : Summary The Business Intelligence, Analytics & Reporting Analyst will gather, analyze, and...
Remote WorkThe Opportunity: The individual in this position supports supervisors, relationship managers, account owners, and engagement leads with certain ACA managed services offerings including, but not...
Senior Information Security Compliance Analyst
- Harrisburg, PA
- 10 days ago
- Harrisburg, PA
- 10 days ago
Company Overview At Motorola Solutions, we believe that everything starts with our people. We're a global close-knit community, united by the relentless pursuit to help keep people safer...
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 WorkCompany : 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
- 20 days ago
- Radnor, PA
- 20 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
- 22 days ago
- King of Prussia, PA
- 22 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
- 22 days ago
- King of Prussia, PA
- 22 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
- 25 days ago
- West Mifflin, PA
- 25 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...
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...
Demographic Data for Pennsylvania
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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
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Policy Development
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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