Regulatory Affairs Specialist Jobs in Sayreville, 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 Brunswick, NJ (4 miles from Sayreville, NJ)
- 5 hours ago
- New Brunswick, NJ (4 miles from Sayreville, NJ)
- 5 hours ago
At Kelly Professional & Industrial, were all about helping you discover whats next in your career. Are you a recent graduate with a keen eye for detail and a passion for data analytics? Do you...
- Holmdel, NJ (11 miles from Sayreville, NJ)
- 13 days ago
- Holmdel, NJ (11 miles from Sayreville, NJ)
- 13 days ago
Guided by our company Purpose of "Inspiring well-being for our colleagues, consumers, and communities," we are committed to building a best-in-class Law Department. We drive a high-performance...
Senior Regulatory Affairs Specialist
- Bridgewater, NJ (16 miles from Sayreville, NJ)
- 29 days ago
- Bridgewater, NJ (16 miles from Sayreville, NJ)
- 29 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...
- Newark, NJ (21 miles from Sayreville, NJ)
- 30+ days ago
- Newark, NJ (21 miles from Sayreville, NJ)
- 30+ days ago
Compliance Analyst Business Operations and Management $ 63 / Hour location_on Newark, New Jerseypass_calibration Remote work_outline Contract/Temporary favorite_border JOB ON CANDIDATE PORTAL COPY...
Principal Specialist, Regulatory Affairs
- Summit, NJ (17 miles from Sayreville, NJ)
- 30+ days ago
- Summit, NJ (17 miles from Sayreville, NJ)
- 30+ days ago
Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patients natural...
Compliance Analyst - Alternative Risk (Remote or Eatontown, NJ)
- Eatontown, NJ (19 miles from Sayreville, NJ)
- 90+ days ago
- Eatontown, NJ (19 miles from Sayreville, NJ)
- 90+ days ago
Crum & Forster Company Overview Crum & Forster (C&F), with a proud history dating to 1822, provides specialty and standard commercial lines insurance products through our admitted and surplus...
Remote WorkDemographic Data for Sayreville, NJ
Moving to Sayreville, NJ? Find some basic demographic data about Sayreville, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Sayreville, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Sayreville, 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
- Engineering
- Risk Management
- Affirmative Action
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Analytical Skills
- Auditing
- 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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