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.
Compliance Analyst - Investment Advisory Compliance
- Philadelphia, PA
- 5 hours ago
- Philadelphia, PA
- 5 hours ago
Compliance Analyst-Investment Advisory Compliance The position’s main responsibilities involve supporting the Investment Advisory CCO in the development, implementation and maintenance of Janney...
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkGuided by our company Purpose of Inspiring well-being for our colleagues, consumers, and communities, we are committed to building a best-in-class Law Department. We drive a high-performance...
Coordinates products in alignment with company policies as well as internal audits and inspections. Oversees all materials required in submissions, license renewal and annual registrations....
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
audits Coordinate audit responses Coordinates Regulatory Agency audits with customers and internal staff Compiling and presenting metrics in relation to their job performance and performance of the...
Responsible for preparation of materials for research compliance committee meetings. Assists with development, implementation, and maintenance of all research compliance program policies and audit...
This role is hybrid (3 days onsite) in Exton/Eagleview, PA. Candidates applying must be residing within a commutable 50 mile radius to the location. Who We Are: At West, were a dedicated team that...
An employer in the Life Sciences industry is looking for a Global Trade Compliance Analyst. This role will be performing data cleansing and classification for a high volume of backlogged product...
Compliance Analyst, AML (Anti-Money Laundering)
- West Mifflin, PA
- 10 days ago
- West Mifflin, PA
- 10 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...
Trade Compliance Analyst Who We Are: GEODIS specializes in unlocking business value in a complex world, ensuring seamless movement of goods worldwide. As a global third-party logistics provider...
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
The Compliance Analyst, Health & Regulatory Compliance Group will support all members of the Health Regulatory & Compliance Group with managing multiple activities and projects required for...
Compliance Analyst - Monroeville, PA (Hybrid)
- Monroeville, PA
- 14 days ago
- Monroeville, PA
- 14 days ago
At CVS Health, were building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nations leading...
Rise Baking Company was founded by bakery experts passionate about providing our customers with high quality products and providing a positive, collaborative place to work for our people. We are a...
Demographic Data for Pennsylvania
Moving to Pennsylvania? Find some basic demographic data about Pennsylvania below.
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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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