Regulatory Affairs Specialist Jobs in Willernie, MN
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 Electrophysiology (on-site)
- Plymouth, MN (23 miles from Willernie, MN)
- 30+ days ago
- Plymouth, MN (23 miles from Willernie, MN)
- 30+ days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
Regulatory Affairs Specialist II - Ventures (on-site)
- Saint Paul, MN (9 miles from Willernie, MN)
- 45+ days ago
- Saint Paul, MN (9 miles from Willernie, MN)
- 45+ days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
Sr Regulatory Affairs Specialist (Remote) - Shockwave
- New Brighton, MN (11 miles from Willernie, MN)
- 22 hours ago
- New Brighton, MN (11 miles from Willernie, MN)
- 22 hours ago
Location: New Brighton, US-MN Rate: Not Specified Type: Permanent Sr Regulatory Affairs Specialist (Remote) - Shockwave At Johnson & Johnson,we believe health is everything....
Remote WorkSr. Regulatory Affairs Associate
- Maplewood, MN (4 miles from Willernie, MN)
- 1 day ago
- Maplewood, MN (4 miles from Willernie, MN)
- 1 day ago
Insight Global is seeking a Sr. Regulatory Affairs Associate to join one of our largest manufacturing clients. As a Senior Regulatory Affairs Associate, you will play a key role in ensuring...
- Brooklyn Park, MN (20 miles from Willernie, MN)
- 1 day ago
- Brooklyn Park, MN (20 miles from Willernie, MN)
- 1 day ago
Pay Range: $75,000 - $80,000 Location: Ideally seated at one of our major facilities in: Brooklyn Park, MN Greenwood, IN Roanoke, VA Sanford, FL Bondurant, IA Willing to consider remote...
- Bloomington, MN (21 miles from Willernie, MN)
- 1 day ago
- Bloomington, MN (21 miles from Willernie, MN)
- 1 day ago
HealthPartners is currently hiring for a Benefits Compliance Analyst. The analyst ensures that HealthPartners remains compliant with the Affordable Care Act (ACA) and other regulatory requirements...
Regulatory Operations Specialist
- Minneapolis, MN (15 miles from Willernie, MN)
- 1 day ago
- Minneapolis, MN (15 miles from Willernie, MN)
- 1 day ago
Strong understanding of FDA regulations related to medical device registration and listing....
Senior Risk & Compliance Analyst
- Saint Paul, MN (9 miles from Willernie, MN)
- 1 day ago
- Saint Paul, MN (9 miles from Willernie, MN)
- 1 day ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
Sr Payroll Tax and Compliance Analyst
- Golden Valley, MN (19 miles from Willernie, MN)
- 3 days ago
- Golden Valley, MN (19 miles from Willernie, MN)
- 3 days ago
Job Duties: + Ensure accurate and timely processing of monthly, quarterly, and annual multistate payroll tax filings and payments in compliance with federal, state, and local regulations....
Regulatory Affairs Specialist - ACM
- Mounds View, MN (11 miles from Willernie, MN)
- 4 days ago
- Mounds View, MN (11 miles from Willernie, MN)
- 4 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
- Minneapolis, MN (15 miles from Willernie, MN)
- 5 days ago
- Minneapolis, MN (15 miles from Willernie, MN)
- 5 days ago
Regulatory Affairs Specialist responsible for reviewing and assessing changes to Class II medical devices, supporting global regulatory compliance, and collaborating with cross-functional teams....
Public Sector Compliance Analyst
- Saint Paul, MN (9 miles from Willernie, MN)
- 7 days ago
- Saint Paul, MN (9 miles from Willernie, MN)
- 7 days ago
Be the spark that brightens days and ignite your career with TTECs award-winning employment experience. As a Public Sector Compliance Analyst working remote in the United States, youll be a part...
Remote WorkCloud Security Risk and Compliance Analyst
- Minneapolis, MN (15 miles from Willernie, MN)
- 7 days ago
- Minneapolis, MN (15 miles from Willernie, MN)
- 7 days ago
At U.S. Bank, were on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and...
Compliance Analyst (R25_0000002183)
- Minneapolis, MN (15 miles from Willernie, MN)
- 9 days ago
- Minneapolis, MN (15 miles from Willernie, MN)
- 9 days ago
We are searching for a Compliance Analyst within the General Counsel's Organization team, who is a hardworking self-starter motivated by achieving and exceeding goals who will support the...
Revenue Cycle Senior Compliance Analyst - Remote
- Eden Prairie, MN (24 miles from Willernie, MN)
- 10 days ago
- Eden Prairie, MN (24 miles from Willernie, MN)
- 10 days ago
Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by...
Remote WorkDemographic Data for Willernie, MN
Moving to Willernie, MN? Find some basic demographic data about Willernie, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Willernie, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Willernie, MN 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
- Cross-Functional Team Management
- Internal Control
- Management Reporting
- Reimbursement
- 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
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Education Experience
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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