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.
- Troy, MI (21 miles from Novi, MI)
- 1 day ago
- Troy, MI (21 miles from Novi, MI)
- 1 day 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....
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 (21 miles from Novi, MI)
- 6 days ago
- Ann Arbor, MI (21 miles from Novi, MI)
- 6 days ago
Support internal audits and quality management system activities, including the investigations of incidents....
Regulatory and Compliance Analyst
- Plymouth, MI (7 miles from Novi, MI)
- 8 days ago
- Plymouth, MI (7 miles from Novi, MI)
- 8 days ago
Regulatory and Compliance Analyst Rivian vision insurance United States, Michigan, Plymouth Jun 05, 2025 About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for...
- Waterford Township, MI (16 miles from Novi, MI)
- 13 days ago
- Waterford Township, MI (16 miles from Novi, MI)
- 13 days ago
IN THIS ROLE: **Are you detail-driven, tech savvy, and passionate about supporting student success behind the scenes?We're looking for a proactive professional to manage district pupil accounting...
- Ypsilanti, MI (19 miles from Novi, MI)
- 16 days ago
- Ypsilanti, MI (19 miles from Novi, MI)
- 16 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...
RN Clinical Regulatory Compliance Specialist
- Royal Oak, MI (19 miles from Novi, MI)
- 17 days ago
- Royal Oak, MI (19 miles from Novi, MI)
- 17 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...
- Farmington Hills, MI (6 miles from Novi, MI)
- 30+ days ago
- Farmington Hills, MI (6 miles from Novi, MI)
- 30+ days ago
Job Requirements Execute and manage internal audits....
Senior NERC Regulatory Compliance Analyst - Solar Plants - NorthStar Clean Energy
- Ann Arbor, MI (21 miles from Novi, MI)
- 30+ days ago
- Ann Arbor, MI (21 miles from Novi, MI)
- 30+ 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...
Transportation Compliance Analyst
- Livonia, MI (10 miles from Novi, MI)
- 30+ days ago
- Livonia, MI (10 miles from Novi, MI)
- 30+ days ago
Transportation Compliance Analyst (US-O) Would you like to join the Logistics Company for the World? DHL Supply Chain is just that. Become an essential part of everyday life, by contributing to an...
IT Security & Compliance Analyst
- Dearborn, MI (20 miles from Novi, MI)
- 45+ days ago
- Dearborn, MI (20 miles from Novi, MI)
- 45+ days ago
IT Security & Compliance Analyst Stefanini Group is hiring! Stefanini is looking for an IT Security & Compliance Analyst, Dearborn, MI (Hybrid) For quick apply, please reach out Saurabh Kapoor at...
Senior NERC Regulatory Compliance Analyst - Gas Plants - NorthStar Clean Energy
- Dearborn, MI (20 miles from Novi, MI)
- 45+ days ago
- Dearborn, MI (20 miles from Novi, 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...
RN Clinical Regulatory Compliance Specialist
- Southfield, MI (12 miles from Novi, MI)
- 45+ days ago
- Southfield, MI (12 miles from Novi, MI)
- 45+ 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...
Senior Regulatory Affairs Specialist 1
- Ann Arbor, MI (21 miles from Novi, MI)
- 60+ days ago
- Ann Arbor, MI (21 miles from Novi, 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 (16 miles from Novi, MI)
- 90+ days ago
- Auburn Hills, MI (16 miles from Novi, 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 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
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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