Regulatory Affairs Specialist Jobs in Neenah, WI
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.
- Menasha, WI (8 miles from Neenah, WI)
- 6 days ago
- Menasha, WI (8 miles from Neenah, WI)
- 6 days ago
. - Assist in performing internal audits and compliance reviews to ensure adherence to policies and regulations....
Conducts internal audits of controls to assess compliance with data security and privacy policies, procedures, standards, and/or regulations....
Summary The Regulatory Compliance Analyst fulfills department responsibilities necessary to ensure regulatory compliance primarily in insurance policy form development, form and rate filing, and...
Energy Compliance Analyst U.S. Energy
- Appleton, WI (9 miles from Neenah, WI)
- 30+ days ago
- Appleton, WI (9 miles from Neenah, WI)
- 30+ days ago
DIVISION: U.S. Energy POSITION SUMMARY The Energy Compliance Analyst will support the Energy division within U.S. Venture. The primary responsibility of the Energy Compliance Analyst is to support...
Demographic Data for Neenah, WI
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Neenah, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Neenah, WI 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
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- 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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