Regulatory Affairs Specialist Jobs in Fair Haven, MI
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.
SEMCO - Senior Regulatory Affairs Specialist (Utilities Regulation)
- Port Huron, MI (22 miles from Fair Haven, MI)
- 27 days ago
- Port Huron, MI (22 miles from Fair Haven, MI)
- 27 days ago
SEMCO - Senior Regulatory Affairs Specialist The Sr....
Regulatory Compliance Specialist Oakland University
- Rochester, MI (24 miles from Fair Haven, MI)
- 45+ days ago
- Rochester, MI (24 miles from Fair Haven, MI)
- 45+ days ago
Position Purpose: The regulatory compliance specialist works under the direction of the IRB Manager at Oakland University to provide ongoing support to the Institutional Review Board (IRB) for the...
SEMCO - Senior Regulatory Affairs Specialist
- Port Huron, MI (22 miles from Fair Haven, MI)
- 60+ days ago
- Port Huron, MI (22 miles from Fair Haven, MI)
- 60+ days ago
SEMCO - Senior Regulatory Affairs Specialist The Sr....
Demographic Data for Fair Haven, MI
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fair Haven, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fair Haven, MI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Flexibility
- Call Center Experience
- Medicare
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- 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
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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