Regulatory Affairs Specialist Jobs in Clinton, 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 (24 miles from Clinton, NJ)
- 2 days ago
- Morristown, NJ (24 miles from Clinton, NJ)
- 2 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...
QA Regulatory Affairs Specialist
- Basking Ridge, NJ (19 miles from Clinton, NJ)
- 7 days ago
- Basking Ridge, NJ (19 miles from Clinton, NJ)
- 7 days ago
QA Regulatory Affairs Specialist Job Description This position requires reviewing label content to ensure accuracy, consistency, and compliance....
- Bridgewater, NJ (16 miles from Clinton, NJ)
- 11 days ago
- Bridgewater, NJ (16 miles from Clinton, NJ)
- 11 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 (23 miles from Clinton, NJ)
- 11 days ago
- Princeton, NJ (23 miles from Clinton, NJ)
- 11 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...
Trade Compliance Analyst (REMOTE)
- Lebanon, NJ (5 miles from Clinton, NJ)
- 17 days ago
- Lebanon, NJ (5 miles from Clinton, NJ)
- 17 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 Work- Princeton, NJ (23 miles from Clinton, NJ)
- 21 days ago
- Princeton, NJ (23 miles from Clinton, NJ)
- 21 days ago
Regulations and ANDA submission Adverse Drug Reporting, IND Safety Reports, PSURs and DSUR Actively participate in the Global Regulatory Affairs meetings...
Regulatory Affairs Specialist Advertising/Promo
- Bridgewater, NJ (16 miles from Clinton, NJ)
- 22 days ago
- Bridgewater, NJ (16 miles from Clinton, NJ)
- 22 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 (16 miles from Clinton, NJ)
- 22 days ago
- Bridgewater, NJ (16 miles from Clinton, NJ)
- 22 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...
- Morristown, NJ (24 miles from Clinton, NJ)
- 45+ days ago
- Morristown, NJ (24 miles from Clinton, NJ)
- 45+ 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...
- Easton, PA (16 miles from Clinton, NJ)
- 90+ days ago
- Easton, PA (16 miles from Clinton, NJ)
- 90+ days ago
Scope: The Senior Trade Compliance Analyst is responsible for supporting and assisting export and/or import activities with oversight and direction from the Global Trade Compliance Manager....
Demographic Data for Clinton, NJ
Moving to Clinton, NJ? Find some basic demographic data about Clinton, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Clinton, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Clinton, 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
- 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
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- 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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