Regulatory Affairs Specialist Jobs in Romulus, 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.
Ethics & Compliance Analyst (Intermediate or Senior Level)
- Novi, MI (20 miles from Romulus, MI)
- 5 days ago
- Novi, MI (20 miles from Romulus, MI)
- 5 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 and Compliance Analyst
- Plymouth, MI (14 miles from Romulus, MI)
- 8 days ago
- Plymouth, MI (14 miles from Romulus, 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...
- Ypsilanti, MI (14 miles from Romulus, MI)
- 17 days ago
- Ypsilanti, MI (14 miles from Romulus, MI)
- 17 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 (22 miles from Romulus, MI)
- 18 days ago
- Royal Oak, MI (22 miles from Romulus, MI)
- 18 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 (21 miles from Romulus, MI)
- 30+ days ago
- Farmington Hills, MI (21 miles from Romulus, MI)
- 30+ days ago
Job Requirements Execute and manage internal audits....
Transportation Compliance Analyst
- Livonia, MI (11 miles from Romulus, MI)
- 30+ days ago
- Livonia, MI (11 miles from Romulus, 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...
Senior NERC Regulatory Compliance Analyst - Gas Plants - NorthStar Clean Energy
- Dearborn, MI (10 miles from Romulus, MI)
- 45+ days ago
- Dearborn, MI (10 miles from Romulus, 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 (20 miles from Romulus, MI)
- 45+ days ago
- Southfield, MI (20 miles from Romulus, 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...
Information Security Governance Risk Compliance Analyst - 2696
- Detroit, MI (17 miles from Romulus, MI)
- 45+ days ago
- Detroit, MI (17 miles from Romulus, MI)
- 45+ days ago
What We Offer: Our excellent salary and benefits package includes medical, dental, vision, life insurance, short and long-term disability coverage, education reimbursement, 401(k), performance...
Systems Controls & Compliance Analyst
- Southfield, MI (20 miles from Romulus, MI)
- 90+ days ago
- Southfield, MI (20 miles from Romulus, 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 Romulus, MI
Moving to Romulus, MI? Find some basic demographic data about Romulus, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Romulus, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Romulus, MI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- 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
- Interpersonal Skills
- 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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