Regulatory Affairs Specialist Jobs in Indiana
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.
Position Summary Position is responsible to provide expertise in infrastructure plan review and permit issuance, ensuring compliance with applicable federal, state, local laws and ordinances, and...
Position is responsible to provide expertise in infrastructure plan review and permit issuance, ensuring compliance with applicable federal, state, local laws and ordinances, and applicable...
Compliance Analyst, Transaction Tax DuCharme, McMillen & Associates, Inc. - 3.2 Indianapolis, IN Job Details Full-time Estimated: $41.2K - $49.7K a year 1 day ago Benefits Paid parental leave...
Regulatory Affairs Specialist - Post Market
- Indianapolis, IN
- 10 days ago
- Indianapolis, IN
- 10 days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkSenior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
Senior Compliance Analyst (Risk Assessment and Oversight) - Remote
- Indianapolis, IN
- 12 days ago
- Indianapolis, IN
- 12 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. **Job Posting...
Remote WorkOverview The Regulatory Affairs Specialist II has primary responsibility for provision of In Vitro Diagnostic regulatory support to prepare, execute and maintain regulatory filings including change...
Pay Range: $75,000 - $80,000 Location: Ideally seated at one of our major facilities in: Brooklyn Park, MN Greenwood, IN Roanoke, VA Sanford, FL Bondurant, IA Willing to consider remote...
Compliance Analyst -Renewable Natural Gas (RNG)
- Indianapolis, IN
- 30+ days ago
- Indianapolis, IN
- 30+ days ago
The Compliance Analyst - RNG 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...
View Job Global Trade Compliance Analyst II (Hybrid) Save to Inbox Email Share Full Time BAE Systems Fort Wayne IN 46809 USA Posted 05/02/2025 Job Description back to top Job Description Join a...
Financial Compliance Analyst (Financial Analyst)
- Richmond, IN
- 45+ days ago
- Richmond, IN
- 45+ days ago
Financial Compliance Analyst (Financial Analyst) Indiana University, United States about 6 hours ago Location: Richmond, INDIANA Job Type: FullTime RESEARCH ADMINISTRATION (UA-RSCH-IUBLA) The...
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...
Demographic Data for Indiana
Moving to Indiana? Find some basic demographic data about Indiana below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Indiana
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Indiana offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Writing Skills
- Data Analysis
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Microsoft Word
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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