Regulatory Affairs Specialist Jobs in Rochester Hills, 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.
RN Clinical Regulatory Compliance Specialist
- Royal Oak, MI (16 miles from Rochester Hills, MI)
- 3 days ago
- Royal Oak, MI (16 miles from Rochester Hills, MI)
- 3 days ago
About Corewell Health Our new name signals our bold commitment to health and wellness. At our core, we are here to help people be well so they can live their healthiest life possible. Through...
RN Clinical Regulatory Compliance Specialist
- Southfield, MI (17 miles from Rochester Hills, MI)
- 7 days ago
- Southfield, MI (17 miles from Rochester Hills, MI)
- 7 days ago
This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Grosse Pointe Hospital. About Corewell Health Our new name...
System Audit & Compliance Analyst
- Southfield, MI (17 miles from Rochester Hills, MI)
- 21 days ago
- Southfield, MI (17 miles from Rochester Hills, MI)
- 21 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 Oakland University
- Rochester, MI
- 30+ days ago
- Rochester, MI
- 30+ 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...
Systems Controls & Compliance Analyst
- Southfield, MI (17 miles from Rochester Hills, MI)
- 90+ days ago
- Southfield, MI (17 miles from Rochester Hills, 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 Hills, MI
Moving to Rochester Hills, MI? Find some basic demographic data about Rochester Hills, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Rochester Hills, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Rochester Hills, 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
- Corrective Actions & Preventive Actions
- 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
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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