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)
- 2 days ago
- Morristown, NJ (18 miles from Edison, NJ)
- 2 days ago
Responsible for closely working with all clinical departments and our technology team to build orders and charges within the electronic medical record as well determine charge capture workflows....
- Dayton, NJ (11 miles from Edison, NJ)
- 2 days ago
- Dayton, NJ (11 miles from Edison, NJ)
- 2 days ago
The Team: The Import Export Team plays a crucial role in ensuring our merchandise and non-merchandise arrive safely and efficiently while adhering to all federal regulations of import/export. Our...
Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred)
- Parsippany, NJ (23 miles from Edison, NJ)
- 3 days ago
- Parsippany, NJ (23 miles from Edison, NJ)
- 3 days ago
Corza Medical Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred) in Parsippany , New Jersey Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred) Location...
Food Safety & Regulatory Compliance Specialist
- Cranbury, NJ (15 miles from Edison, NJ)
- 4 days ago
- Cranbury, NJ (15 miles from Edison, NJ)
- 4 days ago
Support the maintenance and review of key food safety and quality systems, including pest control, sanitation, GMP, and internal auditing....
Standards Compliance Analyst 1 Developmental Disabilities
- New York City, NY (24 miles from Edison, NJ)
- 5 days ago
- New York City, NY (24 miles from Edison, NJ)
- 5 days ago
Please note: State agencies that contact job applicants do not usually request personal or financial information via text message or over the phone in connection with your response to a job...
Senior Regulatory Affairs Specialist, Program Lead
- New Brunswick, NJ (3 miles from Edison, NJ)
- 6 days ago
- New Brunswick, NJ (3 miles from Edison, NJ)
- 6 days ago
Support quality system and technical file/design dossier audits....
Remote WorkSenior Regulatory Affairs Specialist
- Morristown, NJ (18 miles from Edison, NJ)
- 8 days ago
- Morristown, NJ (18 miles from Edison, NJ)
- 8 days ago
This role requires maintaining a thorough understanding of FDA regulations and processes governing the content and maintenance of controlled documents....
Senior Compliance Analyst, Complaints
- New York City, NY (24 miles from Edison, NJ)
- 10 days ago
- New York City, NY (24 miles from Edison, NJ)
- 10 days ago
SENIOR COMPLIANCE ANALYST (COMPLAINTS) Current is a leading U.S. fintech serving people who have been overlooked by traditional banks with nearly 4 million members. Headquartered in NYC, our...
Regulatory Affairs Specialists
- Woodbridge, NJ (6 miles from Edison, NJ)
- 15 days ago
- Woodbridge, NJ (6 miles from Edison, NJ)
- 15 days ago
REGULATORY AFFAIRS SPECIALISTS in Iselin , New Jersey Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes....
Regulatory Affairs Specialists
- Metuchen, NJ (3 miles from Edison, NJ)
- 15 days ago
- Metuchen, NJ (3 miles from Edison, NJ)
- 15 days ago
REGULATORY AFFAIRS SPECIALISTS in Metuchen , New Jersey Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes....
Regulatory Compliance Analyst - Investigations and Data Analysis
- Newark, NJ (19 miles from Edison, NJ)
- 15 days ago
- Newark, NJ (19 miles from Edison, NJ)
- 15 days ago
Job Order Number: DE9362523 Job Title: Regulatory Compliance Analyst - Investigations and Data Analysis Company: NJ Transit Location: Newark, NJ Salary: Education: Less Than High School...
Remote Retirement Plan Compliance Analyst
- Newark, NJ (19 miles from Edison, NJ)
- 17 days ago
- Newark, NJ (19 miles from Edison, NJ)
- 17 days ago
FuturePlan is the nations 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 WorkRegulatory Compliance Analyst - Legal
- Newark, NJ (19 miles from Edison, NJ)
- 18 days ago
- Newark, NJ (19 miles from Edison, NJ)
- 18 days ago
Federal Transit Administration (FTA), Federal Rail Administration (FRA), Federal Motor Coach Safety Administration (FMCSA), or Federal Emergency Management Agency (FEMA)). + Under the direction of Deputy...
- Princeton, NJ (17 miles from Edison, NJ)
- 20 days ago
- Princeton, NJ (17 miles from Edison, NJ)
- 20 days ago
Prepare and maintain regulatory documents in eCTD format for reference and easy retrieval and update the standards in accordance with current FDA regulations, checking for expired/outdated products....
- Parsippany, NJ (23 miles from Edison, NJ)
- 22 days ago
- Parsippany, NJ (23 miles from Edison, NJ)
- 22 days ago
About Blue Foundry Bank This is the Bank Where Things are Made. Blue Foundry is a bank where businesses are shaped, plans are formed, ideas are refined, solutions are built, and stuff gets done....
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
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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