Regulatory Affairs Specialist Jobs in Novi, 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.
Import Trade Compliance Analyst
- Rochester Hills, MI (21 miles from Novi, MI)
- 13 hours ago
- Rochester Hills, MI (21 miles from Novi, MI)
- 13 hours ago
Company Description ABOUT US OESL Original Equipment Solutions, For Future Mobility Are you ready to move Forward Together with a global, dedicated, and experienced team? Join us and take the...
Senior Regulatory Affairs Specialist-FDA Food 1 1
- Ann Arbor, MI (21 miles from Novi, MI)
- 17 days ago
- Ann Arbor, MI (21 miles from Novi, MI)
- 17 days ago
To strengthen our team in Ann Arbor, we are looking for you as a(n) Senior Regulatory Affairs Specialist-FDA Food 1 1....
RN Clinical Regulatory Compliance Specialist
- Southfield, MI (12 miles from Novi, MI)
- 18 days ago
- Southfield, MI (12 miles from Novi, MI)
- 18 days ago
This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health East Region. About Corewell Health Our new name signals...
- Troy, MI (21 miles from Novi, MI)
- 24 days ago
- Troy, MI (21 miles from Novi, MI)
- 24 days ago
We have an exciting opportunity as a Sr. Compliance Analyst to join the team at Ameriprise! In this role you will assist in ensuring communications satisfy regulatory and corporate requirements;...
- Romulus, MI (20 miles from Novi, MI)
- 30+ days ago
- Romulus, MI (20 miles from Novi, MI)
- 30+ days ago
Job Type Full-time Description We are seeking a detail-oriented and experienced BSA Compliance Analyst to support the day-to-day operations of our Bank Secrecy Act (BSA)/Anti-Money Laundering...
- Troy, MI (21 miles from Novi, MI)
- 45+ days ago
- Troy, MI (21 miles from Novi, MI)
- 45+ days ago
Company: Tata Elxsi Limited Position Title: Regulatory Affairs Specialist Location: 2701 Troy Center Drive, Troy, MI 48084 and unanticipated client locations throughout the U.S....
- Ypsilanti, MI (19 miles from Novi, MI)
- 60+ days ago
- Ypsilanti, MI (19 miles from Novi, MI)
- 60+ days ago
Job Title: Regulatory Compliance Analyst Department: Regulatory Compliance Reports To: Regulatory Compliance Manager SUMMARY: Responsible to assist with Company compliance with all applicable...
Demographic Data for Novi, MI
Moving to Novi, MI? Find some basic demographic data about Novi, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Novi, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Novi, 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
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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