Regulatory Affairs Specialist Jobs in Edison, 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.
- Morristown, NJ (18 miles from Edison, NJ)
- 3 days ago
- Morristown, NJ (18 miles from Edison, NJ)
- 3 days ago
Job ID: 25-56140 Duration: 6 Months Location: Irvine, CA (Onsite) Position Summary With general supervision, the Product Compliance Analyst works with external compliance companies to ensure the...
- New York City, NY (24 miles from Edison, NJ)
- 4 days ago
- New York City, NY (24 miles from Edison, NJ)
- 4 days ago
What You'll Do: Analyze and interpret regulatory rules and regulations, and determine impact on new and existing business lines, policies, products, procedures and services Assist in developing,...
Regulatory Affairs Coordinator
- Secaucus, NJ (24 miles from Edison, NJ)
- 5 days ago
- Secaucus, NJ (24 miles from Edison, NJ)
- 5 days ago
Regulatory Affairs Coordinator cGxPServe Secaucus, NJ, United States 4 days ago Quick Job type Full-time Quick Job description Responsibilities : Regulatory Labelling Documentation. Support the...
Food Safety & Regulatory Compliance Specialist
- Cranford, NJ (10 miles from Edison, NJ)
- 10 days ago
- Cranford, NJ (10 miles from Edison, NJ)
- 10 days ago
Competency with Electronic Quality Management Systems (EQCMS) along with excellent organizational skills Self-motivated, proactive thinking Strong knowledge of food safety regulations and standards....
- Bridgewater, NJ (12 miles from Edison, NJ)
- 12 days ago
- Bridgewater, NJ (12 miles from Edison, NJ)
- 12 days ago
Ashland has an exciting opportunity for a Regulatory Affairs Specialist to join our Ashland LLC, Specialty ingredients business at our Bridgewater, NJ or Wilmington, DE locations....
Regulatory Operations Specialist
- Princeton, NJ (17 miles from Edison, NJ)
- 12 days ago
- Princeton, NJ (17 miles from Edison, NJ)
- 12 days ago
Must possess and demonstrate an understanding of FDA Regulations, ISO 13485 Standard, European Medical Device Regulation, Canadian Medical Device Regulations, Japanese QMS Ordinance, Australian Therapeutic...
- Jersey City, NJ (22 miles from Edison, NJ)
- 14 days ago
- Jersey City, NJ (22 miles from Edison, NJ)
- 14 days ago
Compliance Analyst Posted at: 07/15/2025 Jersey City, NJ - NON IT - Compliance / Audit - Contract - Job ID: 25-15025 Role: Compliance Analyst Location: Hybrid in Jersey City, 3-4 days on site...
- New York City, NY (24 miles from Edison, NJ)
- 17 days ago
- New York City, NY (24 miles from Edison, NJ)
- 17 days ago
PingPong is on a mission to digitize trade, simplifying global growth for businesses. With $200B+ in payments processed, we're one of the world's leading cross-border platforms - and we're just...
Trade Compliance Analyst (REMOTE)
- Lebanon, NJ (23 miles from Edison, NJ)
- 18 days ago
- Lebanon, NJ (23 miles from Edison, NJ)
- 18 days ago
Trade Compliance Analyst (REMOTE) - ( 250005G ) **Description** **CONSTRUCTION SPECIALTIES, INC.** Founded in 1948, Construction Specialties (CS) is a specialty building products manufacturer. CS...
Remote WorkRemote Retirement Plan Compliance Analyst
- Newark, NJ (19 miles from Edison, NJ)
- 21 days ago
- Newark, NJ (19 miles from Edison, NJ)
- 21 days ago
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch...
Remote Work- Princeton, NJ (17 miles from Edison, NJ)
- 22 days ago
- Princeton, NJ (17 miles from Edison, NJ)
- 22 days ago
Regulations and ANDA submission Adverse Drug Reporting, IND Safety Reports, PSURs and DSUR Actively participate in the Global Regulatory Affairs meetings...
Compliance Analyst - Operations
- Jersey City, NJ (22 miles from Edison, NJ)
- 22 days ago
- Jersey City, NJ (22 miles from Edison, NJ)
- 22 days ago
Overview** Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New...
Sr. Compliance Analyst, Excess and Surplus P&C (Eatontown, NJ or Remote)
- Eatontown, NJ (23 miles from Edison, NJ)
- 22 days ago
- Eatontown, NJ (23 miles from Edison, NJ)
- 22 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 WorkRegulatory Affairs Specialist Advertising/Promo
- Bridgewater, NJ (12 miles from Edison, NJ)
- 23 days ago
- Bridgewater, NJ (12 miles from Edison, NJ)
- 23 days ago
Regulatory Affairs Specialist Advertising & Promotion Location: Bridgewater, NJ / Hybrid Industry: Pharmaceuticals / Life Sciences Track: Technical (No Direct Reports) Pay Rate: $61-$91/hour Overview...
Regulatory Affairs Specialist - Advertising/Promo
- Bridgewater, NJ (12 miles from Edison, NJ)
- 23 days ago
- Bridgewater, NJ (12 miles from Edison, NJ)
- 23 days ago
Regulatory Affairs Specialist Advertising & Promotion Location: Bridgewater, NJ / Hybrid Industry: Pharmaceuticals / Life Sciences Track: Technical (No Direct Reports) Pay Rate: $61-$91/hour Overview...
Demographic Data for Edison, NJ
Moving to Edison, NJ? Find some basic demographic data about Edison, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Edison, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Edison, 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
- Internal Control
- Management Reporting
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Change Management
- Risk Management
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Written Communication
- Education Experience
- Investigation
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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