Regulatory Affairs Specialist Jobs in Grand Rapids, 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.
Senior Regulatory Affairs Specialist - Cardiac Surgery
- Grand Rapids, MI
- 13 hours ago
- Grand Rapids, MI
- 13 hours ago
A Day in the Life The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for...
Responsible for implementing and maintaining program standards and work plans for assigned financial compliance program. May assist leadership or lead in development of new program or standard...
Job Summary: The Senior Risk & Compliance Analyst works with the Information Security Analyst, Manager, and the Chief Information Security Officer (CISO) managing and coordinating the governance,...
Regulatory Affairs Specialist oversees regulatory affairs activities for the contract development and manufacturing organization (CDMO) where GRAMs clients are the sponsors, application- and license...
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Governance, Risk and Compliance Analyst - M&A
- Grand Rapids, MI
- 60+ days ago
- Grand Rapids, MI
- 60+ days ago
Job Title: Governance, Risk, & Compliance (GRC) Analyst - M&A Department: Information Security Location: Hybrid (4 days onsite, 1 remote) About Acrisure Acrisure is a global Fintech leader that...
Demographic Data for Grand Rapids, MI
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Grand Rapids, MI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Grand Rapids, 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
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Analytical Skills
- 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
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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