Regulatory Affairs Specialist Jobs in Whitestown, 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 (21 miles from Whitestown, IN)
- 6 days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 6 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...
Remote IT Quality Assurance and Compliance, Analyst
- Westfield, IN (9 miles from Whitestown, IN)
- 7 days ago
- Westfield, IN (9 miles from Whitestown, IN)
- 7 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 (21 miles from Whitestown, IN)
- 7 days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 7 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...
Compliance Analyst (Medical Device Industry)
- Indianapolis, IN (21 miles from Whitestown, IN)
- 10 days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 10 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 (21 miles from Whitestown, IN)
- 12 days ago
- Indianapolis, IN (21 miles from Whitestown, 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 Title...
Remote WorkCompliance Analyst -Renewable Natural Gas (RNG)
- Indianapolis, IN (21 miles from Whitestown, IN)
- 30+ days ago
- Indianapolis, IN (21 miles from Whitestown, 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...
Information Security & Compliance Analyst (12 mo. contract)
- Indianapolis, IN (21 miles from Whitestown, IN)
- 45+ days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 45+ days ago
Management and Environmental Management....
Demographic Data for Whitestown, IN
Moving to Whitestown, IN? Find some basic demographic data about Whitestown, IN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Whitestown, IN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Whitestown, IN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- 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
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- 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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