Regulatory Affairs Specialist Jobs in Saline, 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.
Regulatory Compliance Specialist
- Ann Arbor, MI (8 miles from Saline, MI)
- 9 days ago
- Ann Arbor, MI (8 miles from Saline, MI)
- 9 days ago
Support internal audits and quality management system activities, including the investigations of incidents....
Regulatory and Compliance Analyst
- Plymouth, MI (20 miles from Saline, MI)
- 11 days ago
- Plymouth, MI (20 miles from Saline, MI)
- 11 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 (10 miles from Saline, MI)
- 20 days ago
- Ypsilanti, MI (10 miles from Saline, MI)
- 20 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 (8 miles from Saline, MI)
- 30+ days ago
- Ann Arbor, MI (8 miles from Saline, 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...
Senior Regulatory Affairs Specialist 1
- Ann Arbor, MI (8 miles from Saline, MI)
- 60+ days ago
- Ann Arbor, MI (8 miles from Saline, 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....
Demographic Data for Saline, MI
Moving to Saline, MI? Find some basic demographic data about Saline, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Saline, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Saline, 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
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Written Communication
- Writing Skills
- Data Analysis
- Verbal Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Microsoft Word
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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