Regulatory Affairs Specialist Jobs in Michigan
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.
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkAbout 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...
Internal Audit - IT Auditor Cyber Security Services Advisor (formerly Security Controls Champion or Security Controls Practitioner) Preferred candidate should have a proven track record in IT security...
Partner with Credit Application Teams to Implement and manage IT Controls Provide Security & Control consulting to Application teams Internal Audit and Third-Party Audit Support Support Credit Internal...
Senior NERC Regulatory Compliance Analyst - Solar Plants - NorthStar Clean Energy
- Coldwater, MI
- 5 days ago
- Coldwater, MI
- 5 days ago
NorthStar Clean Energy decarbonizes the economy by providing clean energy and carbon management solutions to utility, municipal, commercial, and industrial customers enabling them to meet their...
Senior NERC Regulatory Compliance Analyst - Gas Plants - NorthStar Clean Energy
- Dearborn, MI
- 5 days ago
- Dearborn, MI
- 5 days ago
NorthStar Clean Energy decarbonizes the economy by providing clean energy and carbon management solutions to utility, municipal, commercial, and industrial customers enabling them to meet their...
- Ann Arbor, MI
- 6 days ago
- Ann Arbor, MI
- 6 days ago
Serve as the subject matter expert for accreditation and licensing regulatory compliance within Specialty and Community Pharmacy Services. Engage with state regulatory bodies to initiate and...
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...
Specialty Pharmacy Accreditation & Regulatory Compliance Specialist
- Ann Arbor, MI
- 7 days ago
- Ann Arbor, MI
- 7 days ago
Serve as the subject matter expert for accreditation and licensing regulatory compliance within Specialty and Community Pharmacy Services. Mission Statement Michigan Medicine improves the health...
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Information Security Governance Risk Compliance Analyst - 2696
- Detroit, MI
- 11 days ago
- Detroit, MI
- 11 days ago
What We Offer: Our excellent salary and benefits package includes medical, dental, vision, life insurance, short and long-term disability coverage, education reimbursement, 401(k), performance...
Your Future Evolves Here Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
SEMCO - Senior Regulatory Affairs Specialist (Utilities Regulation)
- Port Huron, MI
- 19 days ago
- Port Huron, MI
- 19 days ago
SEMCO - Senior Regulatory Affairs Specialist The Sr....
Overview Why GMF Technology? GM Financial is set to change the auto finance industry and is leading the path of embarking on tech modernization - we have a startup mindset, and preserve our small...
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 Michigan
Moving to Michigan? Find some basic demographic data about Michigan below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Michigan
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Michigan offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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