Regulatory Affairs Specialist Jobs in Wilmot, 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 II
- Lake Forest, IL (24 miles from Wilmot, WI)
- 13 days ago
- Lake Forest, IL (24 miles from Wilmot, WI)
- 13 days ago
Regulatory Affairs Specialist II Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life....
Senior Specialist - Regulatory Affairs -Transfusion
- Lake Bluff, IL (22 miles from Wilmot, WI)
- 21 days ago
- Lake Bluff, IL (22 miles from Wilmot, WI)
- 21 days ago
Abbott Park : AP08/A ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2...
Senior Specialist - Regulatory Affairs -Transfusion
- Abbott Park, IL (21 miles from Wilmot, WI)
- 24 days ago
- Abbott Park, IL (21 miles from Wilmot, WI)
- 24 days ago
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for on-market regulatory affairs department to ensure efficient and compliant business processes...
Senior Customs Compliance Analyst
- Lake Forest, IL (24 miles from Wilmot, WI)
- 30+ days ago
- Lake Forest, IL (24 miles from Wilmot, WI)
- 30+ days ago
Work Location Type: Hybrid About Grainger: W.W. Grainger, Inc., is a leading broad line distributor with operations primarily in North America, Japan and the United Kingdom. At Grainger, We Keep...
Senior Regulatory Affairs Specialist, Digital Health / Software Products
- Lake Forest, IL (24 miles from Wilmot, WI)
- 45+ days ago
- Lake Forest, IL (24 miles from Wilmot, WI)
- 45+ days ago
As a Senior Regulatory Affairs Specialist within Alcon's Digital Health Quality and Regulatory Affairs (QRA) team, you will be trusted to ensure compliance with regulatory requirements for software...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Wilmot, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Wilmot, WI offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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