Regulatory Affairs Specialist Jobs in Carmel, 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.
Sr. Lead QA Compliance Analyst - HIRING NOW
- Indianapolis, IN (14 miles from Carmel, IN)
- 6 days ago
- Indianapolis, IN (14 miles from Carmel, IN)
- 6 days ago
Experience in industry quality systems/standards. Excellent interpersonal and organizational skills. Ability to influence QA strategy systems/standards....
Compliance Analyst -Renewable Natural Gas (RNG)
- Indianapolis, IN (14 miles from Carmel, IN)
- 7 days ago
- Indianapolis, IN (14 miles from Carmel, IN)
- 7 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...
- Indianapolis, IN (14 miles from Carmel, IN)
- 17 days ago
- Indianapolis, IN (14 miles from Carmel, IN)
- 17 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote Work- Indianapolis, IN (14 miles from Carmel, IN)
- 45+ days ago
- Indianapolis, IN (14 miles from Carmel, IN)
- 45+ days ago
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 Carmel, IN
Moving to Carmel, IN? Find some basic demographic data about Carmel, IN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Carmel, IN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Carmel, 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
- Internal Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Auditing
- Analytical Skills
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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