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.
Analyst Compliance Analyst Indianapolis, IN Compliance Analyst, Indianapolis, IN COMPLIANCE ANALYST BCforward Indianapolis, IN (Onsite) Contractor Job Details Compliance Analyst BCforward is...
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...
Remote IT Quality Assurance and Compliance, Analyst
- Westfield, IN
- 5 days ago
- Westfield, IN
- 5 days ago
Carrington Remote IT Quality Assurance and Compliance, Analyst in Westfield , Indiana Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and accurate...
Remote WorkQuality & Regulatory Compliance Analyst (Hybrid)
- Indianapolis, IN
- 6 days ago
- Indianapolis, IN
- 6 days ago
Summary The Quality and Regulatory Compliance Analyst is an integral role in producing standard compliance data for accreditation and regulatory surveys, internal QRC and Supplier Quality audits and...
Overview Harnessing the strength in our diversity and industry-leading talent of 40,000+ employees across more than 240+ global locations, we develop, design, and manufacture innovative products...
Compliance Analyst (Medical Device Industry)
- Indianapolis, IN
- 9 days ago
- Indianapolis, IN
- 9 days ago
Experience of industry quality systems/standards Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving Able to influence QA strategy systems...
Compliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Indianapolis, IN
- 11 days ago
- Indianapolis, IN
- 11 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 Title...
Remote WorkOverview The Regulatory Affairs Specialist II develops regulatory strategies,obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook international...
Remote WorkCompliance Analyst -Renewable Natural Gas (RNG)
- Indianapolis, IN
- 30+ days ago
- Indianapolis, IN
- 30+ 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...
Regulatory Affairs Analyst Sr Location Hicksville, NY 11801 Job Summary A Senior Regulatory Relations Analyst, brings regulatory subject matter expertise to the firm and works under minimal...
Information Security & Compliance Analyst (12 mo. contract)
- Indianapolis, IN
- 45+ days ago
- Indianapolis, IN
- 45+ days ago
Management and Environmental Management....
Demographic Data for Indiana
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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
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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