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 Regulatory Affairs Consultant - Ad Promo
- Parexel
- Trenton, NJ (3 miles from Morrisville, PA)
- 8 days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 8 days ago
Job Order Number: DF0781847 Job Title: Senior Regulatory Affairs Consultant - Ad Promo Company: Parexel Location: Trenton, NJ Salary: Education: Information Not Provided Experience: Information...
In Person- Silvi Concrete Products, Inc.
- Fairless Hills, PA (1 mile from Morrisville, PA)
- 12 days ago
- Fairless Hills, PA (1 mile from Morrisville, 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,...
RemoteRegulatory Compliance Associate
- Horizon Blue Cross Blue Shield of New Jersey
- Hopewell, NJ (14 miles from Morrisville, PA)
- 19 days ago
- Hopewell, NJ (14 miles from Morrisville, PA)
- 19 days ago
Horizon Blue Cross Blue Shield of New Jersey empowers our members to achieve their best health. For over 90 years, we have been New Jerseys health solutions leader driving innovations that improve...
Hybrid- Ascensus
- Dresher, PA (18 miles from Morrisville, PA)
- 19 days ago
- Dresher, PA (18 miles from Morrisville, PA)
- 19 days ago
Ascensus 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 Person- American Heritage Federal Credit Union
- Feasterville Trevose, PA (9 miles from Morrisville, PA)
- 20 days ago
- Feasterville Trevose, PA (9 miles from Morrisville, 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 Person- The Boeing Company
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 20 days ago
- Mount Laurel, NJ (17 miles from Morrisville, PA)
- 20 days ago
Audit, external consultants) to respond to regulatory requests, findings, audits and/or examinations Keeps abreast of emerging issues, trends, and evolving regulatory requirements in the Compliance...
In PersonHiring Regulatory Affairs Associate II (Hybrid Remote)
- Abacus Service Corporation
- Princeton, NJ (14 miles from Morrisville, PA)
- 29 days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 29 days ago
Regulatory Affairs Associate II Duration: 12 Months Contract Location: Hybrid Remote @ 100 College Rd W, Princeton, NJ - 08540 Hybrid working once fully trained. More on site presence whilst...
HybridRegulatory Affairs Consultant - Clinical Regulatory Affairs
- Parexel
- Trenton, NJ (3 miles from Morrisville, PA)
- 30+ days ago
- Trenton, NJ (3 miles from Morrisville, PA)
- 30+ days ago
Job Order Number: DF0707784 Job Title: Regulatory Affairs Consultant - Clinical Regulatory Affairs Company: Parexel Location: Trenton, NJ Salary: Education: Information Not Provided Experience:...
In PersonSenior Specialist, Regulatory Affairs
- 1000 Merck Sharp & Dohme LLC
- North Wales, PA (23 miles from Morrisville, PA)
- 30+ days ago
- North Wales, PA (23 miles from Morrisville, PA)
- 30+ days ago
The Senior Specialist is responsible for the review and approval of US promotional materials. As a member of the Review Team, work collaboratively with legal, medical, and commercial colleagues to...
HybridSenior Customs & Trade Compliance Analyst
- Abbott
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
In Person- Princeton University
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
Assist internal audit with compliance-related audits and advisory work, as requested. Perform special projects and assignments, as required....
In PersonSpecialist, Regulatory Affairs Operations Publishing
- Taiho Oncology, Inc.
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 45+ days ago
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
Hybrid- Hikma Pharmaceuticals
- Cherry Hill, NJ (21 miles from Morrisville, PA)
- 45+ days ago
- Cherry Hill, NJ (21 miles from Morrisville, PA)
- 45+ days ago
Job Title: Regulatory Affairs Associate JOB PRUPOSE Responsible for ongoing support of regulatory activities, including preparation and submission of Annual Reports, Annual Product Reviews,...
In PersonSenior Regulatory Affairs Specialist
- Wolters Kluwer
- Princeton, NJ (14 miles from Morrisville, PA)
- 60+ days ago
- Princeton, NJ (14 miles from Morrisville, PA)
- 60+ days ago
About the Role: As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets...
In PersonSpecialist, Regulatory Affairs Advertising & Promotion Review
- Tris Pharma
- Monmouth Junction, NJ (19 miles from Morrisville, PA)
- 60+ days ago
- Monmouth Junction, NJ (19 miles from Morrisville, PA)
- 60+ days ago
Apply Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in...
HybridDemographic 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
- 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
- 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
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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