Regulatory Affairs Specialist Jobs in Clarkston, 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.
Compliance Analyst - R25_0000002183
- Troy, MI (15 miles from Clarkston, MI)
- 6 days ago
- Troy, MI (15 miles from Clarkston, MI)
- 6 days ago
We are searching for a Compliance Analyst within the General Counsel's Organization team, who is a hardworking self-starter motivated by achieving and exceeding goals who will support the...
- Troy, MI (15 miles from Clarkston, MI)
- 21 days ago
- Troy, MI (15 miles from Clarkston, MI)
- 21 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 (18 miles from Clarkston, MI)
- 26 days ago
- Novi, MI (18 miles from Clarkston, MI)
- 26 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 - Contingent - Pharmacy Advantage
- Rochester Hills, MI (13 miles from Clarkston, MI)
- 30+ days ago
- Rochester Hills, MI (13 miles from Clarkston, MI)
- 30+ 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...
- Auburn Hills, MI (8 miles from Clarkston, MI)
- 90+ days ago
- Auburn Hills, MI (8 miles from Clarkston, 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 Clarkston, MI
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Clarkston, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Clarkston, MI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Vendor Management
- Cross-Functional Team Management
- Internal Control
- Management Reporting
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Education Experience
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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