Regulatory Affairs Specialist Jobs in Rochester, 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.
Junior Logistics & Compliance Analyst
- Shelby Township, MI (8 miles from Rochester, MI)
- 1 day ago
- Shelby Township, MI (8 miles from Rochester, MI)
- 1 day ago
Who We Are: Since 1906, New Balance has empowered people through sport and craftsmanship to create positive change in communities around the world. We innovate fearlessly, guided by our core...
System Audit & Compliance Analyst
- Southfield, MI (17 miles from Rochester, MI)
- 10 days ago
- Southfield, MI (17 miles from Rochester, MI)
- 10 days ago
OVERVIEW The Systems Risk & Controls Analyst plans and coordinates activities within the Enterprise Systems Management Team to ensure control activities are performed timely and as designed....
Regulatory Compliance Specialist Bookmark this Requisition Print Preview | Apply for this Job Posting Details Posting Details Position Title Regulatory Compliance Specialist Department 2701 -...
Regulatory Compliance Specialist Oakland University
- Rochester, MI
- 29 days ago
- Rochester, MI
- 29 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...
Jr. Logistics & Compliance Analyst
- Shelby Township, MI (8 miles from Rochester, MI)
- 60+ days ago
- Shelby Township, MI (8 miles from Rochester, MI)
- 60+ days ago
WHO WE ARE: Headquartered in Shelby Township, Michigan, Warrior Sports is recognized as one of the sporting goods industrys premier manufacturers of innovative, high-performance, cutting-edge...
- Auburn Hills, MI (9 miles from Rochester, MI)
- 60+ days ago
- Auburn Hills, MI (9 miles from Rochester, MI)
- 60+ days ago
Conduct internal audits to assess adherence to operational and regulatory standards. Prepare for and support external audits by regulatory bodies or third-party organizations....
Systems Controls & Compliance Analyst
- Southfield, MI (17 miles from Rochester, MI)
- 90+ days ago
- Southfield, MI (17 miles from Rochester, MI)
- 90+ days ago
OVERVIEW The Systems Risk & Controls Analyst plans and coordinates activities within the Enterprise Systems Management Team to ensure control activities are performed timely and as designed....
Demographic Data for Rochester, MI
Moving to Rochester, MI? Find some basic demographic data about Rochester, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Rochester, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Rochester, 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
- 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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