Regulatory Affairs Specialist Jobs in Mount Pleasant, 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.
Risk and Compliance Analyst - US Based Remote
- Milwaukee, WI (23 miles from Mount Pleasant, WI)
- 30+ days ago
- Milwaukee, WI (23 miles from Mount Pleasant, WI)
- 30+ days ago
Information security and Data Privacy are at the core of Anywhere and your work efforts will help identify, protect, and govern sensitive data for our business areas as well as internal and...
Remote WorkSr. Regulatory Compliance Analyst
- Milwaukee, WI (23 miles from Mount Pleasant, WI)
- 45+ days ago
- Milwaukee, WI (23 miles from Mount Pleasant, WI)
- 45+ days ago
What part will you play? If youre looking for a place where you can make a meaningful difference, youve found it. The work we do at Markel gives people the confidence to move forward and seize...
Demographic Data for Mount Pleasant, WI
Moving to Mount Pleasant, WI? Find some basic demographic data about Mount Pleasant, WI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Mount Pleasant, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Mount Pleasant, 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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