Regulatory Affairs Specialist Jobs in Newtown, PA
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 (11 miles from Newtown, PA)
- 2 days ago
- Trenton, NJ (11 miles from Newtown, PA)
- 2 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 Work- Trenton, NJ (11 miles from Newtown, PA)
- 9 days ago
- Trenton, NJ (11 miles from Newtown, PA)
- 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...
- Mount Laurel, NJ (21 miles from Newtown, PA)
- 9 days ago
- Mount Laurel, NJ (21 miles from Newtown, PA)
- 9 days ago
Looing for compliance tester within auto, credit cards, commercial and deposit consumer lending divisions. They have a QC independent testing function where they look at previous data of month or...
Business Intelligence and Compliance Analyst- REMOTE
- Trenton, NJ (11 miles from Newtown, PA)
- 10 days ago
- Trenton, NJ (11 miles from Newtown, PA)
- 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 WorkRegulatory Operations Specialist
- Princeton, NJ (17 miles from Newtown, PA)
- 11 days ago
- Princeton, NJ (17 miles from Newtown, PA)
- 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...
International Regulatory Compliance Specialist
- Mount Laurel, NJ (21 miles from Newtown, PA)
- 16 days ago
- Mount Laurel, NJ (21 miles from Newtown, PA)
- 16 days ago
One of our food & beverage manufacturing clients is seeking an International Regulatory Compliance Specialist to join their team on site in Mount Laurel, NJ. This individual is going to be helping...
REMOTE Loan Servicing Compliance Analyst, I
- Cherry Hill, NJ (23 miles from Newtown, PA)
- 16 days ago
- Cherry Hill, NJ (23 miles from Newtown, PA)
- 16 days ago
Come join our amazing team and work remote from home!** The Loan Servicing Compliance Analyst I will be responsible for the provisioning documentation for various audit and exam documentation....
Remote WorkRemote Retirement Plan Compliance Analyst
- Dresher, PA (13 miles from Newtown, PA)
- 18 days ago
- Dresher, PA (13 miles from Newtown, PA)
- 18 days ago
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 Work- Princeton, NJ (17 miles from Newtown, PA)
- 21 days ago
- Princeton, NJ (17 miles from Newtown, PA)
- 21 days ago
Regulations and ANDA submission Adverse Drug Reporting, IND Safety Reports, PSURs and DSUR Actively participate in the Global Regulatory Affairs meetings...
Senior Risk & Compliance Analyst
- Trenton, NJ (11 miles from Newtown, PA)
- 28 days ago
- Trenton, NJ (11 miles from Newtown, PA)
- 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...
Public Sector Compliance Analyst
- Trenton, NJ (11 miles from Newtown, PA)
- 30+ days ago
- Trenton, NJ (11 miles from Newtown, PA)
- 30+ days ago
Be the spark that brightens days and ignite your career with TTECs award-winning employment experience. As a Public Sector Compliance Analyst working remote in the United States, youll be a part...
Remote WorkCompliance Analyst- HMDA Originations
- Fort Washington, PA (15 miles from Newtown, PA)
- 30+ days ago
- Fort Washington, PA (15 miles from Newtown, PA)
- 30+ days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Remote IT Quality Assurance and Compliance, Analyst
- Cherry Hill, NJ (23 miles from Newtown, PA)
- 30+ days ago
- Cherry Hill, NJ (23 miles from Newtown, PA)
- 30+ days ago
Come join our amazing team and work remote from home!** **What youll do:** Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring...
Remote WorkInfo Security Compliance Analyst
- Philadelphia, PA (24 miles from Newtown, PA)
- 45+ days ago
- Philadelphia, PA (24 miles from Newtown, PA)
- 45+ days ago
Info Security Compliance Analyst Info Security Compliance Analyst Company: Boston College Job Location: Chestnut Hill, 02467 Category: Assessment, Accreditation, and Compliance Type: Full-Time...
Remote WorkSr Compliance Analyst- Originations
- Fort Washington, PA (15 miles from Newtown, PA)
- 45+ days ago
- Fort Washington, PA (15 miles from Newtown, PA)
- 45+ days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Demographic Data for Newtown, PA
Moving to Newtown, PA? Find some basic demographic data about Newtown, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Newtown, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Newtown, PA 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
- Interpersonal Skills
- 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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