Regulatory Affairs Specialist Jobs in South Milwaukee, 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.
Regulatory Affairs Specialist I
- Werfen
- Waukesha, WI (19 miles from South Milwaukee, WI)
- 10 days ago
- Waukesha, WI (19 miles from South Milwaukee, WI)
- 10 days ago
Introduction: Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis,...
In PersonQuality Lead Specialist - Regulatory Affairs
- GE Healthcare Technologies Inc.
- Waukesha, WI (19 miles from South Milwaukee, WI)
- 22 days ago
- Waukesha, WI (19 miles from South Milwaukee, WI)
- 22 days ago
Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launches, premarket submissions/registrations,...
In Person- Milwaukee Electric Tool Corporation
- Brookfield, WI (15 miles from South Milwaukee, WI)
- 27 days ago
- Brookfield, WI (15 miles from South Milwaukee, WI)
- 27 days ago
Job Description: WE CREATE EMPOWERED LEADERS! At Milwaukee Tool we firmly believe that our People and our Culture are the secrets to our success -- so we give you unlimited access to everything...
In Person- Milwaukee Electric Tool Corporation
- Brookfield, WI (15 miles from South Milwaukee, WI)
- 27 days ago
- Brookfield, WI (15 miles from South Milwaukee, WI)
- 27 days ago
Job Description: Trade Compliance Analyst II (Data & Analytics Focus) WE CREATE EMPOWERED LEADERS! At Milwaukee Tool we firmly believe that our People and our Culture are the secrets to our...
In PersonAdvertising Compliance Analyst
- Genesis10
- Milwaukee, WI (9 miles from South Milwaukee, WI)
- 30+ days ago
- Milwaukee, WI (9 miles from South Milwaukee, WI)
- 30+ days ago
Advertising Compliance Analyst#26-05001 Milwaukee, WI On-site Contract Starts 4/27/2026 Ends 12/31/2026 Job Description Genesis10 is currently seeking an Advertising Compliance Analyst for a...
In Person ContractCompliance Analyst - 100%Remote
- Genesis10
- Milwaukee, WI (9 miles from South Milwaukee, WI)
- 30+ days ago
- Milwaukee, WI (9 miles from South Milwaukee, WI)
- 30+ days ago
Compliance Analyst - 100%Remote#26-05104 WI Fully Remote Contract Starts 6/01/2026 Ends 6/01/2027 Job Description Genesis10 is currently seeking a Compliance Analyst - Remote position with a Major...
RemoteDemographic Data for South Milwaukee, WI
Moving to South Milwaukee, WI? Find some basic demographic data about South Milwaukee, WI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in South Milwaukee, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in South Milwaukee, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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