Regulatory Affairs Specialist Jobs in Appleton, 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 (6 miles from Appleton, WI)
- 1 day ago
- Menasha, WI (6 miles from Appleton, WI)
- 1 day ago
. - Assist in performing internal audits and compliance reviews to ensure adherence to policies and regulations....
Data Security and Compliance Analyst
- Neenah, WI (9 miles from Appleton, WI)
- 5 days ago
- Neenah, WI (9 miles from Appleton, WI)
- 5 days ago
Conducts internal audits of controls to assess compliance with data security and privacy policies, procedures, standards, and/or regulations....
- Neenah, WI (9 miles from Appleton, WI)
- 22 days ago
- Neenah, WI (9 miles from Appleton, WI)
- 22 days ago
Summary The Regulatory Compliance Analyst fulfills department responsibilities necessary to ensure regulatory compliance primarily in insurance policy form development, form and rate filing, and...
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...
Regulatory Compliance Specialist
- Green Bay, WI (22 miles from Appleton, WI)
- 30+ days ago
- Green Bay, WI (22 miles from Appleton, WI)
- 30+ days ago
Job Summary A Regulatory Compliance Specialist is responsible for developing, implementing, and managing an organization's compliance programs. This role involves ensuring that the company adheres...
Demographic Data for Appleton, WI
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Appleton, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Appleton, 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
- Microsoft Visio
- Resolution
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- 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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