Regulatory Affairs Specialist Jobs in Saline, 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.
- Ann Arbor, MI (8 miles from Saline, MI)
- 7 days ago
- Ann Arbor, MI (8 miles from Saline, MI)
- 7 days ago
Serve as the subject matter expert for accreditation and licensing regulatory compliance within Specialty and Community Pharmacy Services. Engage with state regulatory bodies to initiate and...
Specialty Pharmacy Accreditation & Regulatory Compliance Specialist
- Ann Arbor, MI (8 miles from Saline, MI)
- 7 days ago
- Ann Arbor, MI (8 miles from Saline, MI)
- 7 days ago
Serve as the subject matter expert for accreditation and licensing regulatory compliance within Specialty and Community Pharmacy Services. Mission Statement Michigan Medicine improves the health...
Senior Regulatory Affairs Specialist 1
- Ann Arbor, MI (8 miles from Saline, MI)
- 25 days ago
- Ann Arbor, MI (8 miles from Saline, MI)
- 25 days ago
At our site in Ann Arbor, we are currently looking for a Senior Regulatory Affairs Specialist 1 to be a part of our growing team....
- Ann Arbor, MI (8 miles from Saline, MI)
- 30+ days ago
- Ann Arbor, MI (8 miles from Saline, MI)
- 30+ days ago
Are you a detail-oriented Trade and Compliance Analyst with a sharp eye for product classification and a deep knowledge of HTS schedules? Do you have a knack for navigating trade regulations and...
Demographic Data for Saline, MI
Moving to Saline, MI? Find some basic demographic data about Saline, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Saline, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Saline, MI 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
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- 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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