Regulatory Affairs Specialist Jobs in Bloomfield 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 (7 miles from Bloomfield Hills, MI)
- 3 days ago
- Farmington Hills, MI (7 miles from Bloomfield Hills, MI)
- 3 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...
Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred)
- Detroit, MI (17 miles from Bloomfield Hills, MI)
- 3 days ago
- Detroit, MI (17 miles from Bloomfield Hills, MI)
- 3 days ago
Corza Medical Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred) in Detroit , Michigan Regulatory Affairs Specialist/Senior RA Specialist (East Coast preferred) Location of Work...
- Troy, MI (7 miles from Bloomfield Hills, MI)
- 16 days ago
- Troy, MI (7 miles from Bloomfield 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....
RN Clinical Regulatory Compliance Specialist
- Taylor, MI (21 miles from Bloomfield Hills, MI)
- 29 days ago
- Taylor, MI (21 miles from Bloomfield Hills, MI)
- 29 days ago
This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Taylor, Trenton, and Wayne Hospitals. About Corewell...
- Bloomfield Township, MI
- 45+ days ago
- Bloomfield Township, 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 (16 miles from Bloomfield Hills, MI)
- 45+ days ago
- Shelby Township, MI (16 miles from Bloomfield 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 (6 miles from Bloomfield Hills, MI)
- 45+ days ago
- Auburn Hills, MI (6 miles from Bloomfield 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 (3 miles from Bloomfield Hills, MI)
- 60+ days ago
- Southfield, MI (3 miles from Bloomfield 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 (7 miles from Bloomfield Hills, MI)
- 60+ days ago
- Farmington Hills, MI (7 miles from Bloomfield Hills, MI)
- 60+ days ago
Job Requirements Execute and manage internal audits....
Demographic Data for Bloomfield Hills, MI
Moving to Bloomfield Hills, MI? Find some basic demographic data about Bloomfield Hills, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Bloomfield Hills, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Bloomfield 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
- Institutional Review Board
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- 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
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- 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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