Regulatory Affairs Specialist Jobs in Morrisville, 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.
Senior Risk & Compliance Analyst
- Trenton, NJ (3 miles from Morrisville, PA)
- 2 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 2 days ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
Regulatory Compliance Specialist
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 2 days ago
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 2 days ago
audit, but all in consumer compliance space. + Have to understand sampling methodologies + Must have experience doing outcomes based transactional testing - comparing documentation to data to make...
Public Sector Compliance Analyst
- Trenton, NJ (3 miles from Morrisville, PA)
- 8 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 8 days ago
Be the spark that brightens days and ignite your career with TTECs award-winning employment experience. As a Public Sector Compliance Analyst working remote in the United States, youll be a part...
Remote WorkSr. Specialist, Regulatory Affairs
- North Wales, PA (23 miles from Morrisville, PA)
- 10 days ago
- North Wales, PA (23 miles from Morrisville, PA)
- 10 days ago
regulations, preferred Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage...
Compliance Analyst- HMDA Originations
- Fort Washington, PA (21 miles from Morrisville, PA)
- 11 days ago
- Fort Washington, PA (21 miles from Morrisville, PA)
- 11 days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Remote IT Quality Assurance and Compliance, Analyst
- Cherry Hill, NJ (21 miles from Morrisville, PA)
- 13 days ago
- Cherry Hill, NJ (21 miles from Morrisville, PA)
- 13 days ago
Come join our amazing team and work remote from home!** **What youll do:** Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring...
Remote WorkFood Safety & Regulatory Compliance Specialist
- Cranbury, NJ (17 miles from Morrisville, PA)
- 18 days ago
- Cranbury, NJ (17 miles from Morrisville, PA)
- 18 days ago
Support the maintenance and review of key food safety and quality systems, including pest control, sanitation, GMP, and internal auditing....
Senior Compliance Analyst (Interpretation and Advising) - Remote
- Trenton, NJ (3 miles from Morrisville, PA)
- 23 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 23 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. **Job Posting...
Remote WorkSr Compliance Analyst- Originations
- Fort Washington, PA (21 miles from Morrisville, PA)
- 24 days ago
- Fort Washington, PA (21 miles from Morrisville, PA)
- 24 days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Senior Regulatory Compliance Analyst
- Princeton, NJ (14 miles from Morrisville, PA)
- 25 days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 25 days ago
Posting Details Posted: June 12, 2025 Full-Time Remote Locations Showing 1 location Nationwide Opportunity- Remote Princeton, NJ 08540, USA Job Details Description Location: Remote near any...
Trade Compliance Analyst (Contract Role)
- Colmar, PA (24 miles from Morrisville, PA)
- 25 days ago
- Colmar, PA (24 miles from Morrisville, PA)
- 25 days ago
Dorman was founded on the belief that people should have greater freedom to fix motor vehicles. For over 100 years, we have been driving new solutions, releasing tens of thousands of aftermarket...
Regulatory Affairs Specialist - Post Market
- Trenton, NJ (3 miles from Morrisville, PA)
- 29 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 29 days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote Work- Camden, NJ (24 miles from Morrisville, PA)
- 45+ days ago
- Camden, NJ (24 miles from Morrisville, PA)
- 45+ days ago
COMPANY BACKGROUND Love. It's what makes Subaru, Subaru. As a leading auto brand in the US, we strive to be More Than a Car Company. Subaru believes in being a positive force in the communities in...
International Regulatory Compliance Specialist
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 45+ days ago
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 45+ days ago
One of our food & beverage manufacturing clients is seeking an International Regulatory Compliance Specialist to join their team on site in Mount Laurel, NJ. This individual is going to be helping...
US - Regulatory Affairs Associate II
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
Job Purpose Responsible for supporting Sandoz business registration process, for eCTD submission, electronic document lifecycle, system validation and to review regulatory affairs submissions...
Demographic Data for Morrisville, PA
Moving to Morrisville, PA? Find some basic demographic data about Morrisville, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Morrisville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Morrisville, 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
- Cross-Functional Team 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
- Data Analysis
- Collaboration
- Education Experience
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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