Regulatory Affairs Specialist Jobs in Berkeley Heights, 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.
- New York, NY (22 miles from Berkeley Heights, NJ)
- 10 hours ago
- New York, NY (22 miles from Berkeley Heights, NJ)
- 10 hours ago
Our client in the finance industry is seeking an AML Compliance Analyst to join their team. As an AML Compliance Analyst, you will be part of the Compliance department supporting the AML team. The...
- New York, NY (22 miles from Berkeley Heights, NJ)
- 10 hours ago
- New York, NY (22 miles from Berkeley Heights, NJ)
- 10 hours ago
Our client in the finance industry is seeking an AML Compliance Analyst to join their team. As an AML Compliance Analyst, you will be part of the Compliance department supporting the AML team. The...
- New York, NY (22 miles from Berkeley Heights, NJ)
- 2 days ago
- New York, NY (22 miles from Berkeley Heights, NJ)
- 2 days ago
Location: New York Job Summary The Compliance Analyst is responsible for the collection and analysis of product data and documentation with a proactive approach to assessing risk. The Compliance...
- Morristown, NJ (8 miles from Berkeley Heights, NJ)
- 3 days ago
- Morristown, NJ (8 miles from Berkeley Heights, 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...
Regulatory Affairs Coordinator
- Bogota, NJ (24 miles from Berkeley Heights, NJ)
- 3 days ago
- Bogota, NJ (24 miles from Berkeley Heights, NJ)
- 3 days ago
Con un legado unico en dermatologia y decadas de innovacion de vanguardia, Galderma es el lider emergente en la categoria de dermatologia, presente en aproximadamente 90 paises. Ofrecemos un...
- New York City, NY (21 miles from Berkeley Heights, NJ)
- 5 days ago
- New York City, NY (21 miles from Berkeley Heights, NJ)
- 5 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,...
Lead Compliance Analyst, Money
- New York, NY (22 miles from Berkeley Heights, NJ)
- 5 days ago
- New York, NY (22 miles from Berkeley Heights, NJ)
- 5 days ago
Join a leading fintech company that's democratizing finance for all. Robinhood Markets was founded on a simple idea: that our financial markets should be accessible to all. With customers at the...
Regulatory Affairs Coordinator
- Secaucus, NJ (19 miles from Berkeley Heights, NJ)
- 6 days ago
- Secaucus, NJ (19 miles from Berkeley Heights, NJ)
- 6 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...
- New York, NY (22 miles from Berkeley Heights, NJ)
- 9 days ago
- New York, NY (22 miles from Berkeley Heights, NJ)
- 9 days ago
Role Working closely with the Americas Chief Compliance Officer, this role will be responsible for: Assisting in the administration of the Firm's Code of Ethics Executing periodic compliance...
Food Safety & Regulatory Compliance Specialist
- Cranford, NJ (6 miles from Berkeley Heights, NJ)
- 11 days ago
- Cranford, NJ (6 miles from Berkeley Heights, NJ)
- 11 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 (11 miles from Berkeley Heights, NJ)
- 12 days ago
- Bridgewater, NJ (11 miles from Berkeley Heights, 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 (24 miles from Berkeley Heights, NJ)
- 13 days ago
- Princeton, NJ (24 miles from Berkeley Heights, NJ)
- 13 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...
- New York, NY (22 miles from Berkeley Heights, NJ)
- 13 days ago
- New York, NY (22 miles from Berkeley Heights, NJ)
- 13 days ago
A Career with Point72's Compliance Department The Point72 Compliance department is an industry-leading team of compliance professionals who support global investment and trading activities by...
Insurance Product Development Regulatory Compliance Analyst
- New York, NY (22 miles from Berkeley Heights, NJ)
- 14 days ago
- New York, NY (22 miles from Berkeley Heights, NJ)
- 14 days ago
Argo Group International Holdings, Inc. and American National, US based specialty P&C companies, (together known as BP&C, Inc.) are wholly owned subsidiaries of Brookfield Wealth Solutions, Ltd....
- Jersey City, NJ (18 miles from Berkeley Heights, NJ)
- 15 days ago
- Jersey City, NJ (18 miles from Berkeley Heights, NJ)
- 15 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...
Demographic Data for Berkeley Heights, NJ
Moving to Berkeley Heights, NJ? Find some basic demographic data about Berkeley Heights, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Berkeley Heights, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Berkeley Heights, 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
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Written Communication
- Education Experience
- Investigation
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- 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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