Regulatory Affairs Specialist Jobs in Hackettstown, 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.
Sr. Regulatory Affairs Associate
- Parsippany, NJ (21 miles from Hackettstown, NJ)
- 9 days ago
- Parsippany, NJ (21 miles from Hackettstown, NJ)
- 9 days ago
Regulatory Affairs AssociateJob Description We are seeking a highly skilled and motivated Regulatory Affairs Associate with extensive experience in authoring ANDA submissions, including all...
Senior Regulatory Affairs Specialist
- Bridgewater, NJ (21 miles from Hackettstown, NJ)
- 20 days ago
- Bridgewater, NJ (21 miles from Hackettstown, NJ)
- 20 days ago
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of...
- Easton, PA (22 miles from Hackettstown, NJ)
- 25 days ago
- Easton, PA (22 miles from Hackettstown, NJ)
- 25 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....
Renewable Natural Gas Regulatory Compliance Analyst
- Whippany, NJ (21 miles from Hackettstown, NJ)
- 90+ days ago
- Whippany, NJ (21 miles from Hackettstown, NJ)
- 90+ days ago
Overview When you join Suburban Propane, you become a part of a fast-paced and dynamic company that has been serving its employees and customers for over 95 years. We have an exciting opportunity...
Demographic Data for Hackettstown, NJ
Moving to Hackettstown, NJ? Find some basic demographic data about Hackettstown, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hackettstown, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hackettstown, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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