Regulatory Affairs Specialist Jobs in Fraser, 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.
- Detroit, MI (14 miles from Fraser, MI)
- 14 hours ago
- Detroit, MI (14 miles from Fraser, MI)
- 14 hours ago
City of Detroit Construction and Demolition Department The Program Analyst III - Community Development Specialist III is an experienced-level professional located within the City of Detroit...
IT Security Controls & Compliance Analyst
- Dearborn, MI (19 miles from Fraser, MI)
- 1 day ago
- Dearborn, MI (19 miles from Fraser, MI)
- 1 day ago
Preferred Experience: Internal Audit - IT Auditor. Cyber Security Services Advisor (formerly Security Controls Champion or Security Controls Practitioner)....
- Troy, MI (11 miles from Fraser, MI)
- 18 days ago
- Troy, MI (11 miles from Fraser, 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....
Regulatory Compliance Specialist - Contingent - Pharmacy Advantage
- Rochester Hills, MI (16 miles from Fraser, MI)
- 26 days ago
- Rochester Hills, MI (16 miles from Fraser, MI)
- 26 days ago
Join Henry Ford Health Pharmacy Advantage team as a Contingent Regulatory Compliance Specialist and help support the regulations team. An exciting opportunity for candidates with a strong pharmacy...
Senior NERC Regulatory Compliance Analyst - Gas Plants - NorthStar Clean Energy
- Dearborn, MI (19 miles from Fraser, MI)
- 60+ days ago
- Dearborn, MI (19 miles from Fraser, 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...
Information Security Governance Risk Compliance Analyst - 2696
- Detroit, MI (14 miles from Fraser, MI)
- 60+ days ago
- Detroit, MI (14 miles from Fraser, MI)
- 60+ 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...
- Auburn Hills, MI (18 miles from Fraser, MI)
- 90+ days ago
- Auburn Hills, MI (18 miles from Fraser, 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 Fraser, MI
Moving to Fraser, MI? Find some basic demographic data about Fraser, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fraser, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fraser, 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
- 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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