Regulatory Affairs Specialist Jobs in Morganville, 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.
Hiring Regulatory Affairs Associate II (Hybrid Remote)
- Abacus Service Corporation
- Princeton, NJ (21 miles from Morganville, NJ)
- 29 days ago
- Princeton, NJ (21 miles from Morganville, NJ)
- 29 days ago
Regulatory Affairs Associate II Duration: 12 Months Contract Location: Hybrid Remote @ 100 College Rd W, Princeton, NJ - 08540 Hybrid working once fully trained. More on site presence whilst...
HybridSenior Customs & Trade Compliance Analyst
- Abbott
- Princeton, NJ (21 miles from Morganville, NJ)
- 45+ days ago
- Princeton, NJ (21 miles from Morganville, NJ)
- 45+ days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
In Person- Princeton University
- Princeton, NJ (21 miles from Morganville, NJ)
- 45+ days ago
- Princeton, NJ (21 miles from Morganville, NJ)
- 45+ days ago
Assist internal audit with compliance-related audits and advisory work, as requested. Perform special projects and assignments, as required....
In PersonSpecialist, Regulatory Affairs Operations Publishing
- Taiho Oncology, Inc.
- Princeton, NJ (21 miles from Morganville, NJ)
- 45+ days ago
- Princeton, NJ (21 miles from Morganville, NJ)
- 45+ days ago
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our People...
HybridSenior Specialist, Regulatory Affairs
- ImmunityBio
- Summit, NJ (24 miles from Morganville, NJ)
- 45+ days ago
- Summit, NJ (24 miles from Morganville, NJ)
- 45+ 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...
In PersonSenior Regulatory Affairs Specialist
- Wolters Kluwer
- Princeton, NJ (21 miles from Morganville, NJ)
- 60+ days ago
- Princeton, NJ (21 miles from Morganville, NJ)
- 60+ days ago
About the Role: As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets...
In PersonSpecialist, Regulatory Affairs Advertising & Promotion Review
- Tris Pharma
- Monmouth Junction, NJ (15 miles from Morganville, NJ)
- 60+ days ago
- Monmouth Junction, NJ (15 miles from Morganville, NJ)
- 60+ days ago
Apply Description Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in...
HybridRegulatory Affairs Associate I
- IntelliPro Group
- Clark, NJ (18 miles from Morganville, NJ)
- 60+ days ago
- Clark, NJ (18 miles from Morganville, NJ)
- 60+ days ago
Job Title: Regulatory Affairs Associate I Position Type: Contract (12+ Months) Location: Clark, NJ 07066 Salary Rate: $3036/hour Job Description We are seeking a detail-oriented Regulatory Affairs...
In PersonDemographic Data for Morganville, NJ
Moving to Morganville, NJ? Find some basic demographic data about Morganville, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Morganville, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Morganville, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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