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.
Who We Are: Since 1906, New Balance has empowered people through sport and craftsmanship to create positive change in communities around the world. We innovate fearlessly, guided by our core...
Information Security Governance Risk Compliance Analyst - 2696
- Detroit, MI
- 1 day ago
- Detroit, MI
- 1 day 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
- 8 days ago
- Port Huron, MI
- 8 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....
Regulatory Affairs Associate Location : Portage, MI Hours/Schedule : Mon- Fri 8am- 5pm Type: Contract Overview As a Regulatory Affairs Associate, you will primarily be responsible for supporting...
At our site in Ann Arbor, we are currently looking for a Senior Regulatory Affairs Specialist 1 to be a part of our growing team....
LICENSES or CERTIFICATIONS Required None Preferred (any of the following) Certified in Healthcare Compliance (CHC) Certified Healthcare Internal Audit Professional (CHIAP) SKILLS Demonstrate expert...
Work Flexibility: Hybrid As the Senior Regulatory Affairs Specialist, you will support new product development and sustaining activities for both US and OUS Global Regulatory release by contributing...
Toxicology & Regulatory Compliance Specialist We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford,...
Are you a detail-oriented Trade and Compliance Analyst with a sharp eye for product classification and a deep knowledge of HTS schedules? Do you have a knack for navigating trade regulations and...
Regulatory Affairs Specialist oversees regulatory affairs activities for the contract development and manufacturing organization (CDMO) where GRAMs clients are the sponsors, application- and license...
Regulatory Compliance Specialist Bookmark this Requisition Print Preview | Apply for this Job Posting Details Posting Details Position Title Regulatory Compliance Specialist Department 2701 -...
Regulatory Compliance Specialist Oakland University
- Rochester, MI
- 29 days ago
- Rochester, MI
- 29 days ago
Position Purpose: The regulatory compliance specialist works under the direction of the IRB Manager at Oakland University to provide ongoing support to the Institutional Review Board (IRB) for the...
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
- Medicare
- Internal Control
- Management Reporting
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »