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.
Specialist, Regulatory Affairs Surgical
- Edwards Lifesciences LLC
- Artemas, PA
- 2 days ago
- Artemas, PA
- 2 days ago
May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE's, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files)...
In Person- Universal Health Services
- King of Prussia, PA
- 2 days ago
- King of Prussia, PA
- 2 days ago
Responsibilities (This role has a hybrid schedule with 3 days in office and 2 days flex-remote) Join a dynamic organization driven by our passion for healthcare. UHS is seeking talented...
HybridSupply Chain Compliance Analyst (Contract)
- Masis Staffing Solutions
- Freemansburg, PA
- 3 days ago
- Freemansburg, PA
- 3 days ago
Not Ready Important Notice About the Application Process This position offers use of our AI screening tool as part of the initial candidate review. While completing the AI screening is optional,...
HybridRegulatory Compliance Analyst (Regulatory Specialist II)
- Parker-Hannifin, Corporation
- Erie, PA
- 5 days ago
- Erie, PA
- 5 days ago
Position Summary The Regulatory Compliance Analyst (Regulatory Specialist II) supports global regulatory compliance activities across Parker Lord's three divisions and manufacturing facilities....
In PersonEarned Value Compliance Analyst (Subject Matter Expert)
- Boeing
- Ridley Park, PA
- 5 days ago
- Ridley Park, PA
- 5 days ago
Job Description At Boeing, we innovate and collaborate to make the world a better place. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive,...
HybridWith a company culture rooted in collaboration, expertise and innovation, we aim to promote progress and inspire our clients, employees, investors and communities to achieve their greatest...
Remote HybridSr. Specialist Regulatory Affairs, Medical Devices
- West Pharmaceutical Services
- Exton, PA
- 7 days ago
- Exton, PA
- 7 days ago
Systems R.A.C certification(s) License and Certifications Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred Travel Requirements 10%: Up to 26 business days per year Physical...
Hybrid- Silvi Concrete Products, Inc.
- Fairless Hills, PA
- 12 days ago
- Fairless Hills, PA
- 12 days ago
Overview Title of Position: Security & Compliance Analyst Locations: Fairless Hills, PA (No Remote / Work From Home) Industry Leading Benefits : Medical, Prescription, Dental, Vision, 401K,...
RemoteCLASSIFICATION: Non-exempt REPORTS TO: BSA/AML Compliance Manager JOB DESCRIPTION Summary/Objective Responsible for supporting the Bank's compliance with BSA/AML regulations and OFAC sanctions by...
In PersonIT Audit & Compliance Analyst Position Summary The IT Audit & Compliance Analyst is responsible for driving audit execution and regulatory compliance efforts across the organization, with primary...
In PersonPrincipal Specialist, Regulatory Affairs
- West Pharmaceutical Services
- Exton, PA
- 18 days ago
- Exton, PA
- 18 days ago
(k) device and EU technical documentation submissions....
HybridAscensus is the leading independent technology and service platform powering savings plans across America, providing products and expertise that help nearly 16 million people save for a better...
In PersonRemote Retirement Plan Compliance Analyst
- Ascensus
- Philadelphia, PA
- 19 days ago
- Philadelphia, PA
- 19 days ago
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- American Heritage Federal Credit Union
- Feasterville Trevose, PA
- 20 days ago
- Feasterville Trevose, PA
- 20 days ago
American Heritage Credit Union, a $5+ billion credit union, has an immediate opening for a Compliance Analyst. \n This position will support the Enterprise Risk and Compliance department in the...
In PersonFlexible Work Arrangement: Hybrid The Sr. Compliance Analyst is responsible for securely managing the Account Authorization and associated compliance processes managed by the Identity and Access...
In PersonDemographic 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Systems Applications & Products
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Sales
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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