Regulatory Affairs Specialist Jobs in Lexington, SC
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.
Risk Management & Compliance Analyst II / TG61100438RP
- Columbia, SC (12 miles from Lexington, SC)
- 1 day ago
- Columbia, SC (12 miles from Lexington, SC)
- 1 day ago
Job Responsibilities This position is a re-post. Previous applicants do not need to re-apply.* This is a Temporary Grant Position.* The Agency's mission is to be boldly innovative in improving the...
- Columbia, SC (12 miles from Lexington, SC)
- 4 days ago
- Columbia, SC (12 miles from Lexington, SC)
- 4 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- Columbia, SC (12 miles from Lexington, SC)
- 12 days ago
- Columbia, SC (12 miles from Lexington, SC)
- 12 days ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Risk Management & Compliance Analyst I
- Columbia, SC (12 miles from Lexington, SC)
- 18 days ago
- Columbia, SC (12 miles from Lexington, SC)
- 18 days ago
Job Responsibilities Participates in the planning and execution of IT examinations of financial institutions. May function as lead examiner for IT examinations. Evaluates financial institutions'...
- Columbia, SC (12 miles from Lexington, SC)
- 19 days ago
- Columbia, SC (12 miles from Lexington, SC)
- 19 days ago
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Senior Risk & Compliance Analyst
- Columbia, SC (12 miles from Lexington, SC)
- 30+ days ago
- Columbia, SC (12 miles from Lexington, SC)
- 30+ days ago
LICENSES or CERTIFICATIONS Required None Preferred (any of the following) Certified in Healthcare Compliance (CHC) Certified Healthcare Internal Audit Professional (CHIAP) SKILLS Demonstrate expert...
- Columbia, SC (12 miles from Lexington, SC)
- 45+ days ago
- Columbia, SC (12 miles from Lexington, SC)
- 45+ days ago
Job Type Full-time Description FN America, LLC is a U.S. subsidiary of FN Herstal, S.A., a global leader in the development and manufacturing of high-quality, reliable firearms for military, law...
Demographic Data for Lexington, SC
Moving to Lexington, SC? Find some basic demographic data about Lexington, SC below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Lexington, SC
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Lexington, SC offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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