Regulatory Affairs Specialist Jobs in Franklin, 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.
Sr. Regulatory Affairs Associate
- Morristown, NJ (23 miles from Franklin, NJ)
- 11 days ago
- Morristown, NJ (23 miles from Franklin, NJ)
- 11 days ago
Job Title: Regulatory Affairs Associate Job Description We are seeking a highly skilled and motivated Regulatory Affairs Associate with extensive experience in authoring ANDA submissions,...
International Regulatory Affairs Specialist - Hybrid
- Franklin Lakes, NJ (21 miles from Franklin, NJ)
- 18 days ago
- Franklin Lakes, NJ (21 miles from Franklin, NJ)
- 18 days ago
Summary We are seeking a highly motivated individual to join our team as a Regulatory Affairs (RA) Specialist responsible for supporting the regulatory compliance of medical devices in the EMEA...
Staff Regulatory Affairs Specialist (Hybrid)
- Franklin Lakes, NJ (21 miles from Franklin, NJ)
- 26 days ago
- Franklin Lakes, NJ (21 miles from Franklin, NJ)
- 26 days ago
Summary Staff Regulatory Affairs specialist supporting medication delivery and vascular care products within the BD Medication Delivery Solutions business unit....
Cyber Compliance Analyst - Skillbridge Fellowship
- Franklin Lakes, NJ (21 miles from Franklin, NJ)
- 30+ days ago
- Franklin Lakes, NJ (21 miles from Franklin, NJ)
- 30+ days ago
Summary About BD BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat. It takes the imagination and...
Renewable Natural Gas Regulatory Compliance Analyst
- Whippany, NJ (21 miles from Franklin, NJ)
- 90+ days ago
- Whippany, NJ (21 miles from Franklin, NJ)
- 90+ days ago
Overview When you join Suburban Propane, you become a part of a fast-paced and dynamic company that has been serving its employees and customers for over 95 years. We have an exciting opportunity...
Senior International Trade Compliance Analyst (Hybrid)
- Wayne, NJ (21 miles from Franklin, NJ)
- 90+ days ago
- Wayne, NJ (21 miles from Franklin, NJ)
- 90+ days ago
Job Description Because this role involves a combination of collaborative/in-person and independent work, it will take the form of a hybrid work format, with time onsite and remote. Position can...
Demographic Data for Franklin, NJ
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Franklin, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Franklin, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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