Regulatory Affairs Specialist Jobs in Birmingham, AL
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.
Compliance Analyst - Licensure
- Mountain Brook, AL (4 miles from Birmingham, AL)
- 4 days ago
- Mountain Brook, AL (4 miles from Birmingham, AL)
- 4 days ago
Overview At SCA Health, we believe health care is about people - the patients we serve, the physicians we support and the teammates who push us forward. Behind every successful facility, procedure...
Overview At SCA Health, we believe health care is about people - the patients we serve, the physicians we support and the teammates who push us forward. Behind every successful facility, procedure...
Thank you for your interest in a career at Regions. At Regions, we believe associates deserve more than just a job. We believe in offering performance-driven individuals a place where they can...
Thank you for your interest in a career at Regions. At Regions, we believe associates deserve more than just a job. We believe in offering performance-driven individuals a place where they can...
Assist in assembling and reviewing documentation for internal audits and the annual HMDA data verification conducted by examiners Position Type Full time Compensation Details Pay ranges are job specific...
Overview Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our...
Demographic Data for Birmingham, AL
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Birmingham, AL
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Birmingham, AL 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
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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