Regulatory Affairs Specialist Jobs in East Windsor, NJ
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 Compliance Analyst (Risk Assessment and Oversight) - Remote
- Trenton, NJ (13 miles from East Windsor, NJ)
- 3 hours ago
- Trenton, NJ (13 miles from East Windsor, NJ)
- 3 hours 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 Work- Piscataway, NJ (16 miles from East Windsor, NJ)
- 3 hours ago
- Piscataway, NJ (16 miles from East Windsor, NJ)
- 3 hours ago
Title: Regulatory Affairs Specialist Job Type: Regular Company: Health Research, Inc....
- Rahway, NJ (23 miles from East Windsor, NJ)
- 5 hours ago
- Rahway, NJ (23 miles from East Windsor, NJ)
- 5 hours ago
Pharmaceutical Manufacturing company seeks a Regulatory Affairs Specialist. Resp. include ensuring compliance with FDA regulations, GMP and industry standards....
- Trenton, NJ (13 miles from East Windsor, NJ)
- 7 hours ago
- Trenton, NJ (13 miles from East Windsor, NJ)
- 7 hours ago
. + 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 WorkSenior Compliance Analyst (Interpretation and Advising) - Remote
- Trenton, NJ (13 miles from East Windsor, NJ)
- 1 day ago
- Trenton, NJ (13 miles from East Windsor, NJ)
- 1 day 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 WorkSenior Regulatory Compliance Analyst
- Princeton, NJ (7 miles from East Windsor, NJ)
- 3 days ago
- Princeton, NJ (7 miles from East Windsor, NJ)
- 3 days ago
Location: Remote near any Astound office nationwide Astound Broadband, the sixth-largest cable operator in the United States, is a leading supplier of cutting-edge technology and communications...
Quality Assurance And Regulatory Affairs Specialist
- Piscataway, NJ (16 miles from East Windsor, NJ)
- 4 days ago
- Piscataway, NJ (16 miles from East Windsor, NJ)
- 4 days ago
Job Title: Quality Assurance and Regulatory Affairs Specialist Job Description As a Quality Assurance and Regulatory Affairs Specialist, you will play a crucial role in supporting all activities related...
- Lakewood, NJ (24 miles from East Windsor, NJ)
- 5 days ago
- Lakewood, NJ (24 miles from East Windsor, NJ)
- 5 days ago
Overview YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! The Compliance Analyst is responsible for supporting the daily operations of the...
Regulatory Affairs Specialist - Post Market
- Trenton, NJ (13 miles from East Windsor, NJ)
- 7 days ago
- Trenton, NJ (13 miles from East Windsor, NJ)
- 7 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 WorkSenior Data & Compliance Analyst
- Trenton, NJ (13 miles from East Windsor, NJ)
- 8 days ago
- Trenton, NJ (13 miles from East Windsor, NJ)
- 8 days ago
Senior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
Master of Science degree in Regulatory Affairs for Pharmaceuticals plus two years as Regulatory Affairs Specialist or Pharmaceutical QA Associate required....
- Edison, NJ (15 miles from East Windsor, NJ)
- 24 days ago
- Edison, NJ (15 miles from East Windsor, NJ)
- 24 days ago
Sales Tax Compliance - State Tax - Local Tax - Sales and Use - SALT - Returns - Reporting - CPA - Certified Public Accountant - C.P.A. Are you an experienced Senior Tax Accountant or Tax Manager...
US - Regulatory Affairs Associate II
- Princeton, NJ (7 miles from East Windsor, NJ)
- 27 days ago
- Princeton, NJ (7 miles from East Windsor, NJ)
- 27 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...
Aprio PH - Senior Compliance Analyst
- Clark, NJ (23 miles from East Windsor, NJ)
- 30+ days ago
- Clark, NJ (23 miles from East Windsor, NJ)
- 30+ days ago
Work with a nationally ranked CPA and advisory firm that is passionate for what's next. Aprio has 30 U.S. office locations, one in the Philippines and more than 2,100 team members that speak 60+...
Compliance Analyst - Alternative Risk (Remote or Eatontown, NJ)
- Eatontown, NJ (24 miles from East Windsor, NJ)
- 90+ days ago
- Eatontown, NJ (24 miles from East Windsor, NJ)
- 90+ days ago
Crum & Forster Company Overview Crum & Forster (C&F), with a proud history dating to 1822, provides specialty and standard commercial lines insurance products through our admitted and surplus...
Remote WorkDemographic Data for East Windsor, NJ
Moving to East Windsor, NJ? Find some basic demographic data about East Windsor, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in East Windsor, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in East Windsor, NJ offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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