Regulatory Affairs Specialist Jobs in Big Bend, 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.
Sr. Lead Specialist, Regulatory Affairs
- Waukesha, WI (9 miles from Big Bend, WI)
- 21 hours ago
- Waukesha, WI (9 miles from Big Bend, WI)
- 21 hours ago
The Senior Regulatory Affairs Specialist will be involved with regulatory activities in the areas such as premarket submissions, regulatory intelligence, regulatory requirements flow-down, advertising...
GSARA Regulatory Compliance Associate
- Racine, WI (24 miles from Big Bend, WI)
- 11 days ago
- Racine, WI (24 miles from Big Bend, WI)
- 11 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 Compliance Specialist II
- Brookfield, WI (13 miles from Big Bend, WI)
- 21 days ago
- Brookfield, WI (13 miles from Big Bend, WI)
- 21 days ago
Job Description: WE CREATE EMPOWERED LEADERS! At Milwaukee Tool, we believe our people and culture are the keys to our success. We are committed to empowering employees with the resources and...
International Trade Compliance Analyst - Level 2 - Hybrid Telework
- Milwaukee, WI (18 miles from Big Bend, WI)
- 30+ days ago
- Milwaukee, WI (18 miles from Big Bend, WI)
- 30+ days ago
Description:We are committed to work life balance by promoting this hybrid telework opportunity. These job requirements allow you to work at our Milwaukee, WI or Orlando, FL facility for part of...
Remote WorkSr. Regulatory Compliance Analyst
- Milwaukee, WI (18 miles from Big Bend, WI)
- 90+ days ago
- Milwaukee, WI (18 miles from Big Bend, WI)
- 90+ 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 Big Bend, WI
Moving to Big Bend, WI? Find some basic demographic data about Big Bend, WI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Big Bend, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Big Bend, 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
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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