Regulatory Affairs Specialist Jobs in Somerville, 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.
- Bridgewater, NJ (2 miles from Somerville, NJ)
- 15 hours ago
- Bridgewater, NJ (2 miles from Somerville, NJ)
- 15 hours ago
Regulatory Affairs Specialist Kelly Science and Clinical is seeking a Regulatory Affairs Specialist for our client a leading medical device company in Bridgewater, NJ....
- East Hanover, NJ (22 miles from Somerville, NJ)
- 1 day ago
- East Hanover, NJ (22 miles from Somerville, NJ)
- 1 day ago
Description : Work with Customs team to implement efficient importation processes into the U.S., as well as facilitate a process to analyze customs value declarations for accuracy, and correct...
- Clark, NJ (18 miles from Somerville, NJ)
- 7 days ago
- Clark, NJ (18 miles from Somerville, NJ)
- 7 days ago
Our client, a global cosmetics company, is looking for a Trade Compliance Manager to join their team! This will be a hybrid role working out of their office in Clark, NJ. The successful candidate...
Sr. Specialist, Regulatory Affairs
- Rahway, NJ (20 miles from Somerville, NJ)
- 7 days ago
- Rahway, NJ (20 miles from Somerville, NJ)
- 7 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...
- Woodbridge, NJ (19 miles from Somerville, NJ)
- 8 days ago
- Woodbridge, NJ (19 miles from Somerville, NJ)
- 8 days ago
Job ID Number R5576 Employment Type Full time Worksite Flexibility Onsite Job Summary The Compliance Analyst will be responsible for preparing legal and evidentiary documentation, reviewing police...
- Raritan, NJ (1 mile from Somerville, NJ)
- 8 days ago
- Raritan, NJ (1 mile from Somerville, NJ)
- 8 days ago
The Trade Compliance Senior Analyst is a subject matter expert in the functional area of Trade Compliance, focusing on international trade flows and import/export documentation and brokerage...
- Morris Plains, NJ (20 miles from Somerville, NJ)
- 10 days ago
- Morris Plains, NJ (20 miles from Somerville, NJ)
- 10 days ago
audits and assessments to identify areas of improvement and implement corrective actions Provide guidance and support to internal stakeholders on trade compliance matters, including training and awareness...
Food Safety & Regulatory Compliance Specialist
- Cranbury, NJ (19 miles from Somerville, NJ)
- 15 days ago
- Cranbury, NJ (19 miles from Somerville, NJ)
- 15 days ago
Support the maintenance and review of key food safety and quality systems, including pest control, sanitation, GMP, and internal auditing....
- Clark, NJ (18 miles from Somerville, NJ)
- 15 days ago
- Clark, NJ (18 miles from Somerville, NJ)
- 15 days ago
We are searching for a motivated Manager to join our Trade Compliance team. The Manager will be responsible for helping prepare monthly reports, manage customs value changes, conduct customs entry...
- Piscataway, NJ (10 miles from Somerville, NJ)
- 18 days ago
- Piscataway, NJ (10 miles from Somerville, NJ)
- 18 days ago
Title: Regulatory Affairs Specialist Job Type: Regular Company: Health Research, Inc....
Senior Regulatory Compliance Analyst
- Princeton, NJ (14 miles from Somerville, NJ)
- 22 days ago
- Princeton, NJ (14 miles from Somerville, NJ)
- 22 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...
- Florham Park, NJ (18 miles from Somerville, NJ)
- 24 days ago
- Florham Park, NJ (18 miles from Somerville, NJ)
- 24 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...
- Morristown, NJ (16 miles from Somerville, NJ)
- 29 days ago
- Morristown, NJ (16 miles from Somerville, NJ)
- 29 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...
- Parsippany, NJ (22 miles from Somerville, NJ)
- 30+ days ago
- Parsippany, NJ (22 miles from Somerville, NJ)
- 30+ days ago
Trade Compliance AnalystPBF Energy Inc. (NYSE:PBF) is one of the largest independent refiners in North America, operating through its subsidiaries, oil refineries and related facilities. We are...
- Rahway, NJ (20 miles from Somerville, NJ)
- 30+ days ago
- Rahway, NJ (20 miles from Somerville, NJ)
- 30+ days ago
Pharmaceutical Manufacturing company seeks a Regulatory Affairs Specialist. Resp. include ensuring compliance with FDA regulations, GMP and industry standards....
Demographic Data for Somerville, NJ
Moving to Somerville, NJ? Find some basic demographic data about Somerville, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Somerville, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Somerville, NJ 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
- Internal Control
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Education Experience
- Collaboration
- 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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