Regulatory Affairs Specialist Jobs in Rochester Hills, 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.
Associate HR Compliance Analyst
- Farmington Hills, MI (20 miles from Rochester Hills, MI)
- 2 days ago
- Farmington Hills, MI (20 miles from Rochester Hills, MI)
- 2 days ago
Company Description We Are Bosch. At Bosch, we shape the future by inventing high-quality technologies and services that spark enthusiasm and enrich people's lives. Our areas of activity are every...
- Troy, MI (8 miles from Rochester Hills, MI)
- 16 days ago
- Troy, MI (8 miles from Rochester Hills, MI)
- 16 days ago
Job Description: 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....
- Bloomfield Township, MI (14 miles from Rochester Hills, MI)
- 45+ days ago
- Bloomfield Township, MI (14 miles from Rochester Hills, MI)
- 45+ days ago
What it's about The Marketing Compliance Analyst will be part of a global team that reviews all marketing presentations promoting the firm's services and products. The position will involve...
Jr. Logistics & Compliance Analyst
- Shelby Township, MI (8 miles from Rochester Hills, MI)
- 45+ days ago
- Shelby Township, MI (8 miles from Rochester Hills, MI)
- 45+ days ago
WHO WE ARE: Headquartered in Shelby Township, Michigan, Warrior Sports is recognized as one of the sporting goods industrys premier manufacturers of innovative, high-performance, cutting-edge...
- Auburn Hills, MI (9 miles from Rochester Hills, MI)
- 45+ days ago
- Auburn Hills, MI (9 miles from Rochester Hills, MI)
- 45+ 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....
Systems Controls & Compliance Analyst
- Southfield, MI (17 miles from Rochester Hills, MI)
- 60+ days ago
- Southfield, MI (17 miles from Rochester Hills, MI)
- 60+ 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....
- Farmington Hills, MI (20 miles from Rochester Hills, MI)
- 60+ days ago
- Farmington Hills, MI (20 miles from Rochester Hills, MI)
- 60+ days ago
Job Requirements Execute and manage internal audits....
Demographic Data for Rochester Hills, MI
Moving to Rochester Hills, MI? Find some basic demographic data about Rochester Hills, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Rochester Hills, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Rochester Hills, MI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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