Regulatory Affairs Specialist Jobs in River Falls, 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.
Senior Regulatory Affairs Associate
- Maplewood, MN (24 miles from River Falls, WI)
- 3 days ago
- Maplewood, MN (24 miles from River Falls, WI)
- 3 days ago
Management District (SCAQMD), and Ozone Transport Commission (OTC) Volatile Organic Compound (VOC) rules/regulations and requirements Experience with systems/business processes relevant to Regulatory...
Regulatory Affairs Specialist I
- Saint Paul, MN (24 miles from River Falls, WI)
- 12 days ago
- Saint Paul, MN (24 miles from River Falls, WI)
- 12 days ago
The Opportunity We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in St. Paul, MN....
- Saint Paul, MN (24 miles from River Falls, WI)
- 14 days ago
- Saint Paul, MN (24 miles from River Falls, WI)
- 14 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkTrade Compliance Analyst - Free Trade Agreements
- Maplewood, MN (24 miles from River Falls, WI)
- 16 days ago
- Maplewood, MN (24 miles from River Falls, WI)
- 16 days ago
Job Description: Job Title Trade Compliance Analyst Free Trade Agreements Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your...
Regulatory Affairs Coordinator
- Saint Paul, MN (24 miles from River Falls, WI)
- 24 days ago
- Saint Paul, MN (24 miles from River Falls, WI)
- 24 days ago
Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments....
Senior Regulatory Affairs Specialist (Solventum)
- Saint Paul, MN (24 miles from River Falls, WI)
- 28 days ago
- Saint Paul, MN (24 miles from River Falls, WI)
- 28 days ago
Job Description: Senior Regulatory Affairs Specialist (Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives....
Senior Regulatory Affairs Specialist
- Stillwater, MN (19 miles from River Falls, WI)
- 45+ days ago
- Stillwater, MN (19 miles from River Falls, WI)
- 45+ days ago
Submit product and quality system changes to the notified body. Participate in regulatory training and transfer the information back to the Regulatory department providing insightful application....
Principal Regulatory Affairs Specialist - Vascular (on-site)
- Saint Paul, MN (24 miles from River Falls, WI)
- 60+ days ago
- Saint Paul, MN (24 miles from River Falls, WI)
- 60+ days ago
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)....
Demographic Data for River Falls, WI
Moving to River Falls, WI? Find some basic demographic data about River Falls, WI below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in River Falls, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in River Falls, 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
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Analytical Skills
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- 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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