Regulatory Affairs Specialist Jobs in Wixom, 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.
IT Security Controls & Compliance Analyst
- Dearborn, MI (23 miles from Wixom, MI)
- 1 day ago
- Dearborn, MI (23 miles from Wixom, MI)
- 1 day ago
Preferred Experience: Internal Audit - IT Auditor. Cyber Security Services Advisor (formerly Security Controls Champion or Security Controls Practitioner)....
- Romulus, MI (24 miles from Wixom, MI)
- 2 days ago
- Romulus, MI (24 miles from Wixom, MI)
- 2 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 Wixom, MI)
- 18 days ago
- Troy, MI (21 miles from Wixom, MI)
- 18 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....
Ethics & Compliance Analyst (Intermediate or Senior Level)
- Novi, MI (3 miles from Wixom, MI)
- 22 days ago
- Novi, MI (3 miles from Wixom, MI)
- 22 days ago
Job Summary Supports on-going coordination of the company's Corporate Compliance framework. Assists in the administration of compliance programs and processes. Analyzes compliance data and...
Regulatory Compliance Specialist
- Ann Arbor, MI (23 miles from Wixom, MI)
- 23 days ago
- Ann Arbor, MI (23 miles from Wixom, MI)
- 23 days ago
Support internal audits and quality management system activities, including the investigations of incidents....
- Ypsilanti, MI (22 miles from Wixom, MI)
- 30+ days ago
- Ypsilanti, MI (22 miles from Wixom, MI)
- 30+ 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...
Senior NERC Regulatory Compliance Analyst - Solar Plants - NorthStar Clean Energy
- Ann Arbor, MI (23 miles from Wixom, MI)
- 45+ days ago
- Ann Arbor, MI (23 miles from Wixom, MI)
- 45+ days ago
NorthStar Clean Energy decarbonizes the economy by providing clean energy and carbon management solutions to utility, municipal, commercial, and industrial customers enabling them to meet their...
Senior NERC Regulatory Compliance Analyst - Gas Plants - NorthStar Clean Energy
- Dearborn, MI (23 miles from Wixom, MI)
- 60+ days ago
- Dearborn, MI (23 miles from Wixom, MI)
- 60+ days ago
NorthStar Clean Energy decarbonizes the economy by providing clean energy and carbon management solutions to utility, municipal, commercial, and industrial customers enabling them to meet their...
Senior Regulatory Affairs Specialist 1
- Ann Arbor, MI (23 miles from Wixom, MI)
- 60+ days ago
- Ann Arbor, MI (23 miles from Wixom, MI)
- 60+ 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....
- Auburn Hills, MI (15 miles from Wixom, MI)
- 90+ days ago
- Auburn Hills, MI (15 miles from Wixom, MI)
- 90+ 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....
Demographic Data for Wixom, MI
Moving to Wixom, MI? Find some basic demographic data about Wixom, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Wixom, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Wixom, MI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Vendor Management
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Writing Skills
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Critical Thinking
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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