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.
- Troy, MI (8 miles from Rochester Hills, MI)
- 1 day ago
- Troy, MI (8 miles from Rochester Hills, MI)
- 1 day 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
- 9 days ago
- Rochester Hills, MI
- 9 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...
- Waterford Township, MI (12 miles from Rochester Hills, MI)
- 14 days ago
- Waterford Township, MI (12 miles from Rochester Hills, MI)
- 14 days ago
IN THIS ROLE: **Are you detail-driven, tech savvy, and passionate about supporting student success behind the scenes?We're looking for a proactive professional to manage district pupil accounting...
RN Clinical Regulatory Compliance Specialist
- Royal Oak, MI (16 miles from Rochester Hills, MI)
- 18 days ago
- Royal Oak, MI (16 miles from Rochester Hills, MI)
- 18 days ago
About Corewell Health Our new name signals our bold commitment to health and wellness. At our core, we are here to help people be well so they can live their healthiest life possible. Through...
- Farmington Hills, MI (20 miles from Rochester Hills, MI)
- 30+ days ago
- Farmington Hills, MI (20 miles from Rochester Hills, MI)
- 30+ days ago
Job Requirements Execute and manage internal audits....
RN Clinical Regulatory Compliance Specialist
- Southfield, MI (17 miles from Rochester Hills, MI)
- 45+ days ago
- Southfield, MI (17 miles from Rochester Hills, MI)
- 45+ 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 (9 miles from Rochester Hills, MI)
- 90+ days ago
- Auburn Hills, MI (9 miles from Rochester Hills, 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....
Systems Controls & Compliance Analyst
- Southfield, MI (17 miles from Rochester Hills, MI)
- 90+ days ago
- Southfield, MI (17 miles from Rochester Hills, 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 Rochester Hills, MI
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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
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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