Regulatory Affairs Specialist Jobs in Plymouth, 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.
Internal Audit/SOX Compliance Analyst II
- Detroit, MI (24 miles from Plymouth, MI)
- 3 days ago
- Detroit, MI (24 miles from Plymouth, MI)
- 3 days ago
Support the SOX program by performing control testing, including walkthroughs and evaluating the design and operational effectiveness of controls.... Coordinate SOX program testing of controls wit...
Compliance Analyst (MI Health Plan) - REMOTE Eastern Time
- Detroit, MI (24 miles from Plymouth, MI)
- 15 days ago
- Detroit, MI (24 miles from Plymouth, MI)
- 15 days ago
JOB DESCRIPTION Job Summary Molina Healthcare's Compliance team supports compliance operations for all Molina product lines enterprise wide. It is a centralized corporate function supporting...
Remote WorkSenior Regulatory Affairs Specialist-FDA Food 1 1
- Ann Arbor, MI (17 miles from Plymouth, MI)
- 16 days ago
- Ann Arbor, MI (17 miles from Plymouth, MI)
- 16 days ago
To strengthen our team in Ann Arbor, we are looking for you as a(n) Senior Regulatory Affairs Specialist-FDA Food 1 1....
RN Clinical Regulatory Compliance Specialist
- Southfield, MI (15 miles from Plymouth, MI)
- 17 days ago
- Southfield, MI (15 miles from Plymouth, MI)
- 17 days ago
This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health East Region. About Corewell Health Our new name signals...
- Detroit, MI (24 miles from Plymouth, MI)
- 30+ days ago
- Detroit, MI (24 miles from Plymouth, MI)
- 30+ days ago
City of Detroit Construction and Demolition Department The Program Analyst III - Community Development Specialist III is an experienced-level professional located within the City of Detroit...
- Romulus, MI (14 miles from Plymouth, MI)
- 30+ days ago
- Romulus, MI (14 miles from Plymouth, MI)
- 30+ days ago
Job Type Full-time Description We are seeking a detail-oriented and experienced BSA Compliance Analyst to support the day-to-day operations of our Bank Secrecy Act (BSA)/Anti-Money Laundering...
- Ypsilanti, MI (11 miles from Plymouth, MI)
- 60+ days ago
- Ypsilanti, MI (11 miles from Plymouth, MI)
- 60+ days ago
Job Title: Regulatory Compliance Analyst Department: Regulatory Compliance Reports To: Regulatory Compliance Manager SUMMARY: Responsible to assist with Company compliance with all applicable...
Information Security Governance Risk Compliance Analyst - 2696
- Detroit, MI (24 miles from Plymouth, MI)
- 90+ days ago
- Detroit, MI (24 miles from Plymouth, MI)
- 90+ 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...
Demographic Data for Plymouth, MI
Moving to Plymouth, MI? Find some basic demographic data about Plymouth, MI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Plymouth, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Plymouth, MI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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