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.
Summary of This Role Performs and assists in development of enterprise-level risk management and operational compliance functions. Assists in establishing and maintaining risk policies and...
Apply Description Job Purpose: The Regulatory Compliance Specialist will be responsible for leading and managing comprehensive product and environmental reporting requirements. This position will...
audits to evaluate for compliance with regulatory standards (i.e., GCP) Provide guidance and consultation for regulatory inspections Provide consultation and oversight for investigators engaged in...
Remote WorkAbout Us** Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in...
Business Intelligence and Compliance Analyst- REMOTE
- Indianapolis, IN
- 7 days ago
- Indianapolis, IN
- 7 days ago
Job Seekers can review the Job Applicant Privacy Policy by clicking here ( ). Job Description : Summary The Business Intelligence, Analytics & Reporting Analyst will gather, analyze, and...
Remote WorkDetails 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...
Come join our amazing team and work remote from home!** The Loan Servicing Compliance Analyst I will be responsible for the provisioning documentation for various audit and exam documentation....
Remote WorkIn-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...
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
Be the spark that brightens days and ignite your career with TTECs award-winning employment experience. As a Public Sector Compliance Analyst working remote in the United States, youll be a part...
Remote WorkJob 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...
Remote IT Quality Assurance and Compliance, Analyst
- Westfield, IN
- 30+ days ago
- Westfield, IN
- 30+ days ago
Come join our amazing team and work remote from home!** **What youll do:** Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring...
Remote WorkSenior Financial Controls Compliance Analyst
- Evansville, IN
- 30+ days ago
- Evansville, IN
- 30+ days ago
CenterPoint Energy and its predecessor companies have been in business for more than 150 years. Our Vision: Our vision is to become the most admired utility in the United States through the...
Experience : Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent Knowledge and application of 21 CFR 820 and ISO 13485 is required Knowledge and application...
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
- Finance
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Policy Development
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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