Regulatory Affairs Specialist Jobs in Benet Lake, 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.
- Vernon Hills, IL (21 miles from Benet Lake, WI)
- 11 days ago
- Vernon Hills, IL (21 miles from Benet Lake, WI)
- 11 days ago
About Learning Resources: We are on a mission to bring learning to life! We are Learning Resources®, and learning is where we play. Voted one of the Chicago Tribune’s Top Workplaces every year for...
Compliance Analyst (TX Health Plan) - REMOTE Central Time
- Kenosha, WI (11 miles from Benet Lake, WI)
- 14 days ago
- Kenosha, WI (11 miles from Benet Lake, WI)
- 14 days ago
**Job Summary** Molina Healthcare's Compliance team supports compliance operations for all Molina product lines enterprise wide. It is a centralized corporate function supporting compliance...
Remote WorkRegulatory Affairs Associate II
- North Chicago, IL (17 miles from Benet Lake, WI)
- 25 days ago
- North Chicago, IL (17 miles from Benet Lake, WI)
- 25 days ago
Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies. Technical writing skills Familiar with typical manufacturing processes, especially cell...
GSARA Regulatory Compliance Associate
- Racine, WI (17 miles from Benet Lake, WI)
- 30+ days ago
- Racine, WI (17 miles from Benet Lake, WI)
- 30+ days ago
REQUIRED EDUCATION: High School Diploma or Equivalent TOP 5 REQUIRED SKILLS: 1. Strong attention to detail and organizational skills 2. Ability to work independently and as part of a team 3....
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Benet Lake, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Benet Lake, 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
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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