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.
Marketing Regulatory Compliance Specialist (Pharma)
- Indianapolis, IN (21 miles from Whitestown, IN)
- 1 day ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 1 day ago
Remote Marketing Regulatory Compliance SpecialistPosition OverviewA leading pharmaceutical organization is seeking a highly motivated Marketing Compliance Specialist to join its Enablement Team....
Remote WorkRegulatory Compliance Specialist (On-site)
- Indianapolis, IN (21 miles from Whitestown, IN)
- 9 days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 9 days ago
Apply Description Job Purpose: The Regulatory Compliance Specialist will be responsible for leading and managing comprehensive product and environmental reporting requirements. This position will...
Property Tax Compliance Analyst
- Indianapolis, IN (21 miles from Whitestown, IN)
- 18 days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 18 days ago
Details Department: Accounting Property and Assets Schedule: Full Time: Monday-Friday Location: Remote, must reside near Indianapolis Benefits Paid time off (PTO) Various health insurance options...
- Indianapolis, IN (21 miles from Whitestown, IN)
- 26 days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 26 days ago
In-office required. This position will be located in Indianapolis, IN. As a member of JD Finish Line's People Department, the Sr. HR Compliance Analyst will support the organization through the...
- Indianapolis, IN (21 miles from Whitestown, IN)
- 30+ days ago
- Indianapolis, IN (21 miles from Whitestown, IN)
- 30+ days ago
Job Description: Job Title Regulatory Affairs Associate Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and...
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
- Finance
- Financial Services
- Internal Control
- Reimbursement
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Written Communication
- Education Experience
- Documentation
- Investigation
- Verbal Communication
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Project Management
- Problem Solving
- Regulations
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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