Regulatory Affairs Specialist Jobs in Zionsville, IN
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.
- Indianapolis, IN (17 miles from Zionsville, IN)
- 1 day ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 1 day ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
- Indianapolis, IN (17 miles from Zionsville, IN)
- 8 days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 8 days ago
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Senior Regulatory Compliance Analyst
- Indianapolis, IN (17 miles from Zionsville, IN)
- 8 days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 8 days ago
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Global Affairs Job Details About...
Contracts Compliance Analyst II
- Indianapolis, IN (17 miles from Zionsville, IN)
- 24 days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 24 days ago
Overview Medxcel is here to lead the transformation of healthcare facilities management by incorporating a new approach to providing services. Created by healthcare, for healthcare, we have a...
Governance, Risk, and Compliance Analyst
- Indianapolis, IN (17 miles from Zionsville, IN)
- 24 days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 24 days ago
Job Summary: As a GRC Analyst, your role on the team will include leveraging your knowledge of security policies, standards, controls, and industry best practices to consult with others in the...
- Indianapolis, IN (17 miles from Zionsville, IN)
- 27 days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 27 days ago
Compliance Analyst Date: Mar 18, 2025 Location: Indianapolis, IN, US Company: Odyssey Hudson is a market-leading specialty insurer that offers a wide range of property and casualty insurance...
Vendor Compliance Analyst, IN - Hybrid - McLaren Careers
- Indianapolis, IN (17 miles from Zionsville, IN)
- 27 days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 27 days ago
McLaren Health Care Vendor Compliance Analyst, IN - Hybrid - McLaren Careers in Indianapolis , Indiana We are looking for a Vendor Compliance Analyst, to join us in leading our organization...
- Indianapolis, IN (17 miles from Zionsville, IN)
- 30+ days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 30+ days ago
Bachelors degree in Information Security, Compliance, Law, Finance, or a related field. 4+ years of experience in compliance, IT risk management, data privacy, or internal audit, with a focus on ISO...
- Indianapolis, IN (17 miles from Zionsville, IN)
- 30+ days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 30+ days ago
Compliance Analyst III Job Description Job Title: Compliance Analyst III/ Senior QA Compliance Auditor Duration: 6 Months (CONTRACT TO HIRE POSSIBILITY) Shift Time: 8:00 AM to 5:00 PM Mon-Fri (1st...
Compliance Analyst -Renewable Natural Gas (RNG)
- Indianapolis, IN (17 miles from Zionsville, IN)
- 60+ days ago
- Indianapolis, IN (17 miles from Zionsville, IN)
- 60+ days ago
The Business Process Analyst is a key member of the commercial operations and compliance team and will report to the Manager of Commercial Operations. This role 1) takes leadership in the...
Demographic Data for Zionsville, IN
Moving to Zionsville, IN? Find some basic demographic data about Zionsville, IN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Zionsville, IN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Zionsville, IN 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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