Regulatory Affairs Specialist Jobs in Somerset, 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 (22 miles from Somerset, NJ)
- 23 hours ago
- Trenton, NJ (22 miles from Somerset, NJ)
- 23 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 (4 miles from Somerset, NJ)
- 1 day ago
- Piscataway, NJ (4 miles from Somerset, NJ)
- 1 day ago
Title: Regulatory Affairs Specialist Job Type: Regular Company: Health Research, Inc....
- Rahway, NJ (14 miles from Somerset, NJ)
- 1 day ago
- Rahway, NJ (14 miles from Somerset, NJ)
- 1 day ago
Pharmaceutical Manufacturing company seeks a Regulatory Affairs Specialist. Resp. include ensuring compliance with FDA regulations, GMP and industry standards....
- Trenton, NJ (22 miles from Somerset, NJ)
- 1 day ago
- Trenton, NJ (22 miles from Somerset, NJ)
- 1 day 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 (22 miles from Somerset, NJ)
- 2 days ago
- Trenton, NJ (22 miles from Somerset, 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 (11 miles from Somerset, NJ)
- 4 days ago
- Princeton, NJ (11 miles from Somerset, NJ)
- 4 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...
- Newark, NJ (24 miles from Somerset, NJ)
- 5 days ago
- Newark, NJ (24 miles from Somerset, NJ)
- 5 days ago
Compliance Analyst, ANV AmTrust Financial life insurance, paid time off, 401(k) United States, Jersey, Morristown Jun 06, 2025 Compliance Analyst, ANV Job Locations US-NJ-TBD Requisition ID...
Quality Assurance And Regulatory Affairs Specialist
- Piscataway, NJ (4 miles from Somerset, NJ)
- 5 days ago
- Piscataway, NJ (4 miles from Somerset, NJ)
- 5 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...
- Florham Park, NJ (20 miles from Somerset, NJ)
- 6 days ago
- Florham Park, NJ (20 miles from Somerset, NJ)
- 6 days ago
Our client is looking to fill the role of Regulatory Affairs Associate. This role is hybrid and based out Livingston, NJ. Responsibilities: Stay up to date with current regulatory requirements and...
Regulatory Affairs Specialist - Post Market
- Trenton, NJ (22 miles from Somerset, NJ)
- 8 days ago
- Trenton, NJ (22 miles from Somerset, NJ)
- 8 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 (22 miles from Somerset, NJ)
- 9 days ago
- Trenton, NJ (22 miles from Somerset, NJ)
- 9 days ago
Senior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
- Morristown, NJ (19 miles from Somerset, NJ)
- 11 days ago
- Morristown, NJ (19 miles from Somerset, NJ)
- 11 days ago
Responsibilities include but are not limited to: Administer HMDA and CRA data collection processes, including testing and data integrity reviews. Provide compliance-related and regulatory guidance...
- Edison, NJ (6 miles from Somerset, NJ)
- 25 days ago
- Edison, NJ (6 miles from Somerset, 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...
Regional FSTDO Standards & Regulatory Compliance Specialist
- Whippany, NJ (23 miles from Somerset, NJ)
- 26 days ago
- Whippany, NJ (23 miles from Somerset, NJ)
- 26 days ago
About This Role Support the FSTDO Standards & Compliance Manager in work related to ensuring FSTDO standards and regulatory compliance for the assigned region, responsibilities include but not...
Regulatory Compliance Associate
- Newark, NJ (24 miles from Somerset, NJ)
- 26 days ago
- Newark, NJ (24 miles from Somerset, NJ)
- 26 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...
Demographic Data for Somerset, NJ
Moving to Somerset, NJ? Find some basic demographic data about Somerset, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Somerset, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Somerset, 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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