Regulatory Affairs Specialist Jobs in Lake Orion, 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.
Senior Financial Compliance Analyst
- Southfield, MI (15 miles from Lake Orion, MI)
- 4 days ago
- Southfield, MI (15 miles from Lake Orion, MI)
- 4 days ago
Job Summary Responsible for implementing and maintaining program standards and work plans for assigned financial compliance program. May assist leadership or lead in development of new program or...
Regulatory Compliance Specialist
- Madison Heights, MI (17 miles from Lake Orion, MI)
- 11 days ago
- Madison Heights, MI (17 miles from Lake Orion, MI)
- 11 days ago
We are on a mission to grow Second Nature Brands 4x from $500MM to $1+B in the next 4 years through a combination of organic growth (increased distribution, e-commerce, and innovation) and through...
RN Clinical Regulatory Compliance Specialist
- Southfield, MI (15 miles from Lake Orion, MI)
- 20 days ago
- Southfield, MI (15 miles from Lake Orion, MI)
- 20 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...
- Auburn Hills, MI (6 miles from Lake Orion, MI)
- 90+ days ago
- Auburn Hills, MI (6 miles from Lake Orion, 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....
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Systems Controls & Compliance Analyst
- Southfield, MI (15 miles from Lake Orion, MI)
- 90+ days ago
- Southfield, MI (15 miles from Lake Orion, 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 Lake Orion, MI
Moving to Lake Orion, MI? Find some basic demographic data about Lake Orion, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Lake Orion, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Lake Orion, 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
- Internal Control
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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