Regulatory Affairs Specialist Jobs in Hopewell, 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 Hopewell, NJ)
- 12 hours ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 12 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 (19 miles from Hopewell, NJ)
- 13 hours ago
- Piscataway, NJ (19 miles from Hopewell, NJ)
- 13 hours ago
Title: Regulatory Affairs Specialist Job Type: Regular Company: Health Research, Inc....
- Trenton, NJ (13 miles from Hopewell, NJ)
- 17 hours ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 17 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 Hopewell, NJ)
- 2 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 2 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 WorkSenior Regulatory Compliance Analyst
- Princeton, NJ (6 miles from Hopewell, NJ)
- 3 days ago
- Princeton, NJ (6 miles from Hopewell, 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 (19 miles from Hopewell, NJ)
- 4 days ago
- Piscataway, NJ (19 miles from Hopewell, 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...
Regulatory Affairs Specialist - Post Market
- Trenton, NJ (13 miles from Hopewell, NJ)
- 7 days ago
- Trenton, NJ (13 miles from Hopewell, 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 Hopewell, NJ)
- 8 days ago
- Trenton, NJ (13 miles from Hopewell, 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...
- East Windsor, NJ (14 miles from Hopewell, NJ)
- 16 days ago
- East Windsor, NJ (14 miles from Hopewell, NJ)
- 16 days ago
Master of Science degree in Regulatory Affairs for Pharmaceuticals plus two years as Regulatory Affairs Specialist or Pharmaceutical QA Associate required....
- Edison, NJ (21 miles from Hopewell, NJ)
- 25 days ago
- Edison, NJ (21 miles from Hopewell, NJ)
- 25 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 (6 miles from Hopewell, NJ)
- 27 days ago
- Princeton, NJ (6 miles from Hopewell, 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...
Demographic Data for Hopewell, NJ
Moving to Hopewell, NJ? Find some basic demographic data about Hopewell, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hopewell, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hopewell, NJ offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- 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
- Interpersonal Skills
- 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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