Regulatory Affairs Specialist Jobs in Hopewell, 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.
- Trenton, NJ (13 miles from Hopewell, NJ)
- 3 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 3 days ago
Our mission is to make higher education accessible and affordable for everyone.** We empower students with financial support and supercharge their ability to pay down their debt, so they can get...
Remote WorkQA Regulatory Affairs Specialist
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 7 days ago
- Basking Ridge, NJ (21 miles from Hopewell, NJ)
- 7 days ago
QA Regulatory Affairs Specialist Job Description This position requires reviewing label content to ensure accuracy, consistency, and compliance....
- Trenton, NJ (13 miles from Hopewell, NJ)
- 9 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 9 days ago
About Us** Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in...
Business Intelligence and Compliance Analyst- REMOTE
- Trenton, NJ (13 miles from Hopewell, NJ)
- 10 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 10 days ago
_Job Seekers can review the Job Applicant Privacy Policy by clicking here (._ **Job Description** : **Summary** The Business Intelligence, Analytics & Reporting Analyst will gather, analyze, and...
Remote Work- Bridgewater, NJ (15 miles from Hopewell, NJ)
- 11 days ago
- Bridgewater, NJ (15 miles from Hopewell, 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 (6 miles from Hopewell, NJ)
- 11 days ago
- Princeton, NJ (6 miles from Hopewell, 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 (16 miles from Hopewell, NJ)
- 17 days ago
- Lebanon, NJ (16 miles from Hopewell, 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 (6 miles from Hopewell, NJ)
- 21 days ago
- Princeton, NJ (6 miles from Hopewell, 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 (15 miles from Hopewell, NJ)
- 22 days ago
- Bridgewater, NJ (15 miles from Hopewell, 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 (15 miles from Hopewell, NJ)
- 22 days ago
- Bridgewater, NJ (15 miles from Hopewell, 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...
Senior Risk & Compliance Analyst
- Trenton, NJ (13 miles from Hopewell, NJ)
- 28 days ago
- Trenton, NJ (13 miles from Hopewell, NJ)
- 28 days ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
- Piscataway, NJ (19 miles from Hopewell, NJ)
- 45+ days ago
- Piscataway, NJ (19 miles from Hopewell, NJ)
- 45+ days ago
Title: Regulatory Affairs Specialist Job Type: Regular Company: Health Research, Inc....
Demographic Data for Hopewell, NJ
Moving to Hopewell, NJ? Find some basic demographic data about Hopewell, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hopewell, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hopewell, 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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