Regulatory Affairs Specialist Jobs in Hudson, 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
- Little Canada, MN (22 miles from Hudson, WI)
- 9 hours ago
- Little Canada, MN (22 miles from Hudson, WI)
- 9 hours ago
Minnesota > St. Paul > Lillehei : One Lillehei Plaza ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Sr Regulatory Affairs Specialist (Remote) - Shockwave
- New Brighton, MN (24 miles from Hudson, WI)
- 3 days ago
- New Brighton, MN (24 miles from Hudson, WI)
- 3 days ago
Sr Regulatory Affairs Specialist (Remote) - Shockwave- Function Regulatory Affairs Group- Sub function Regulatory Affairs- Category Experienced Analyst, Regulatory Affairs (P5)- Location New Brighton...
Remote Work- Saint Paul, MN (18 miles from Hudson, WI)
- 4 days ago
- Saint Paul, MN (18 miles from Hudson, WI)
- 4 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 (16 miles from Hudson, WI)
- 6 days ago
- Maplewood, MN (16 miles from Hudson, WI)
- 6 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...
- Saint Paul, MN (18 miles from Hudson, WI)
- 12 days ago
- Saint Paul, MN (18 miles from Hudson, WI)
- 12 days ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Regulatory Affairs Coordinator
- Saint Paul, MN (18 miles from Hudson, WI)
- 14 days ago
- Saint Paul, MN (18 miles from Hudson, WI)
- 14 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 (18 miles from Hudson, WI)
- 18 days ago
- Saint Paul, MN (18 miles from Hudson, WI)
- 18 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....
- Saint Paul, MN (18 miles from Hudson, WI)
- 18 days ago
- Saint Paul, MN (18 miles from Hudson, WI)
- 18 days ago
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Senior Risk & Compliance Analyst
- Saint Paul, MN (18 miles from Hudson, WI)
- 29 days ago
- Saint Paul, MN (18 miles from Hudson, WI)
- 29 days ago
LICENSES or CERTIFICATIONS Required None Preferred (any of the following) Certified in Healthcare Compliance (CHC) Certified Healthcare Internal Audit Professional (CHIAP) SKILLS Demonstrate expert...
Regulatory Operations Specialist I
- Little Canada, MN (22 miles from Hudson, WI)
- 30+ days ago
- Little Canada, MN (22 miles from Hudson, WI)
- 30+ days ago
Minnesota > St. Paul > Lillehei : One Lillehei Plaza ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous...
Senior Regulatory Affairs Specialist
- Stillwater, MN (9 miles from Hudson, WI)
- 30+ days ago
- Stillwater, MN (9 miles from Hudson, WI)
- 30+ 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 (18 miles from Hudson, WI)
- 45+ days ago
- Saint Paul, MN (18 miles from Hudson, WI)
- 45+ 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)....
Global Respiratory Protection Regulatory Affairs Specialist
- Maplewood, MN (16 miles from Hudson, WI)
- 60+ days ago
- Maplewood, MN (16 miles from Hudson, WI)
- 60+ days ago
In this role as Global Respiratory Protection Regulatory Affairs Specialist you will play a key role in advancing occupational health and safety (OHS) culture and practice across 3Ms global markets....
Demographic Data for Hudson, WI
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hudson, WI
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hudson, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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