Regulatory Affairs Specialist Jobs in West Caldwell, 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.
Regulatory Affairs Specialist - Labeling
- New York, NY (16 miles from West Caldwell, NJ)
- 20 hours ago
- New York, NY (16 miles from West Caldwell, NJ)
- 20 hours ago
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and...
- Bogota, NJ (13 miles from West Caldwell, NJ)
- 20 hours ago
- Bogota, NJ (13 miles from West Caldwell, NJ)
- 20 hours 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...
IT Cyber Security Risk and Compliance Analyst
- New York, NY (16 miles from West Caldwell, NJ)
- 2 days ago
- New York, NY (16 miles from West Caldwell, NJ)
- 2 days ago
About ITT: At ITT, we have a clear purpose as an organization - to provide our customers with cutting-edge solutions to help solve their most critical needs across key global end markets. Our...
Remote Work- Parsippany, NJ (6 miles from West Caldwell, NJ)
- 3 days ago
- Parsippany, NJ (6 miles from West Caldwell, NJ)
- 3 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....
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CBP Customs Compliance Analyst (Bilingual English
- Englewood Cliffs, NJ (17 miles from West Caldwell, NJ)
- 3 days ago
- Englewood Cliffs, NJ (17 miles from West Caldwell, NJ)
- 3 days ago
at LG Electronics USA, Inc. in Englewood Cliffs, New Jersey, United States Job Description Step into the innovative world of LG Electronics. As a global leader in technology, LG Electronics is...
- Bogota, NJ (13 miles from West Caldwell, NJ)
- 3 days ago
- Bogota, NJ (13 miles from West Caldwell, NJ)
- 3 days ago
Regulatory Affairs Associate Location: Bogota, Colombia About the job We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives....
Cyber Compliance Analyst - Skillbridge Fellowship (Remote)
- Franklin Lakes, NJ (11 miles from West Caldwell, NJ)
- 4 days ago
- Franklin Lakes, NJ (11 miles from West Caldwell, NJ)
- 4 days ago
Summary About BD BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat. It takes the imagination and...
- Roseland, NJ (2 miles from West Caldwell, NJ)
- 5 days ago
- Roseland, NJ (2 miles from West Caldwell, NJ)
- 5 days ago
ADP is hiring a Software Compliance Analyst in our Global Procurement Organization. This role involves ensuring our organizations adherence to open-source software licenses, mitigating legal...
- New York, NY (16 miles from West Caldwell, NJ)
- 5 days ago
- New York, NY (16 miles from West Caldwell, NJ)
- 5 days ago
Overview Fanatics is seeking a motivated, team-oriented state compliance analyst with 2-4+ years of applicable experience in a compliance, legal, or regulatory operations role (gaming industry...
- New York, NY (16 miles from West Caldwell, NJ)
- 5 days ago
- New York, NY (16 miles from West Caldwell, NJ)
- 5 days ago
, a division of UMB Bank n.a. Are you ready to be part of something more? You're more than a means to an end-a way to help us meet the bottom line. UMB isn't comprised of workers, but of people...
Compliance Analyst II - Taxable Fixed Income
- New York, NY (16 miles from West Caldwell, NJ)
- 5 days ago
- New York, NY (16 miles from West Caldwell, NJ)
- 5 days ago
What You'll Be Doing The Compliance Analyst II-Taxable Fixed Income is member of our Institutional Compliance Team. The position is responsible for gathering regulatory reporting data, compiling...
- New York, NY (16 miles from West Caldwell, NJ)
- 6 days ago
- New York, NY (16 miles from West Caldwell, NJ)
- 6 days ago
Compliance Analyst Position Details Assist with the administration of the Firms global Quantitative Trading Compliance program, including the initial vetting and ongoing review of portfolio...
- New York City, NY (17 miles from West Caldwell, NJ)
- 7 days ago
- New York City, NY (17 miles from West Caldwell, NJ)
- 7 days ago
About the Agency: The New York City Department of Housing Preservation Development (HPD) promotes quality and affordability in the city's housing, and diversity and strength in the city's...
Senior Regulatory Affairs Specialist
- Wayne, NJ (6 miles from West Caldwell, NJ)
- 8 days ago
- Wayne, NJ (6 miles from West Caldwell, NJ)
- 8 days ago
Requires skills and experience to include: Experience with ISO 13485, 21 CFR Part 820 FDA QSR (Quality System Regulation), ISO 14971, IEC 62366-1, IEC 60601 Series, IEC 62304 and ISO/TR 20416 standards...
- Hasbrouck Heights, NJ (11 miles from West Caldwell, NJ)
- 8 days ago
- Hasbrouck Heights, NJ (11 miles from West Caldwell, NJ)
- 8 days ago
audit and regulatory examination requests, engage with business units to address findings and help prepare responses....
Demographic Data for West Caldwell, NJ
Moving to West Caldwell, NJ? Find some basic demographic data about West Caldwell, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in West Caldwell, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in West Caldwell, 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
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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