Regulatory Affairs Specialist Jobs in New Jersey
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.
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch...
Remote WorkRegulations and ANDA submission Adverse Drug Reporting, IND Safety Reports, PSURs and DSUR Actively participate in the Global Regulatory Affairs meetings...
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and...
Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New York State,...
Sr. Compliance Analyst, Excess and Surplus P&C (Eatontown, NJ or Remote)
- Eatontown, NJ
- 3 days ago
- Eatontown, NJ
- 3 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 WorkRegulatory Affairs Specialist - Advertising/Promo
- Bridgewater, NJ
- 3 days ago
- Bridgewater, NJ
- 3 days ago
Regulatory Affairs Specialist Advertising & Promotion** **Location:** Bridgewater, NJ / Hybrid **Industry:** Pharmaceuticals / Life Sciences **Track:** Technical (No Direct Reports) **Pay Rate:** $61...
Regulatory Affairs Specialist - Advertising/Promo
- Bridgewater, NJ
- 3 days ago
- Bridgewater, NJ
- 3 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...
Rush Street Interactive (NYSE: RSI) is a market leader in online casino and sports betting, currently operating real-money gaming with our brands: BetRivers.com, PlaySugarHouse.com, and...
Regulatory Affairs Specialist - Franklin Lakes, NJ
- Franklin Lakes, NJ
- 5 days ago
- Franklin Lakes, NJ
- 5 days ago
Regulatory Affairs Specialist independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance....
Skills required: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD....
ADP is hiring a Senior Software Compliance Analyst. Are you a Senior Analyst with Software Asset Management experience, and the skills to help us manage and track software licenses to minimize...
This is an opportunity to join Ascot Group - one of the world's preeminent specialty risk underwriting organizations. Designed as a modern-era company operating through an ecosystem of...
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
Regulatory Affairs Specialist** Kelly Science and Clinical is seeking a **Regulatory Affairs Specialist** **for** our client a leading medical device company in Bridgewater, NJ....
Regulatory Affairs Specialist Kelly Science and Clinical is seeking a Regulatory Affairs Specialist for our client a leading medical device company in Bridgewater, NJ....
Demographic Data for New Jersey
Moving to New Jersey? Find some basic demographic data about New Jersey below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in New Jersey
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in New Jersey offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Policy Development
- Bachelor's Degree
- Microsoft PowerPoint
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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