Regulatory Affairs Specialist Jobs in Arden Hills, 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 (12 miles from Arden Hills, MN)
- 45+ days ago
- Plymouth, MN (12 miles from Arden Hills, MN)
- 45+ days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
Regulatory Operations Specialist I
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 2 days ago
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 2 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...
Regulatory Operations Specialist I
- Little Canada, MN (4 miles from Arden Hills, MN)
- moments ago
- Little Canada, MN (4 miles from Arden Hills, MN)
- moments 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...
Regulatory Affairs Specialist II
- Minnetonka, MN (14 miles from Arden Hills, MN)
- 1 day ago
- Minnetonka, MN (14 miles from Arden Hills, MN)
- 1 day ago
Participate in development and implementation of departmental policies and procedures Foster a work environment of continuous improvement that supports BSCs Quality Policy, Quality System and the appropriate...
Investment Reporting and Compliance Analyst (Hybrid)
- Plymouth, MN (12 miles from Arden Hills, MN)
- 1 day ago
- Plymouth, MN (12 miles from Arden Hills, MN)
- 1 day ago
Our employees are at the heart of what we do: helping people, businesses and society prosper in good times and be resilient in bad times. When you join our team, you are bringing this purpose to...
- Eden Prairie, MN (15 miles from Arden Hills, MN)
- 1 day ago
- Eden Prairie, MN (15 miles from Arden Hills, MN)
- 1 day ago
Compliance Analyst - Remote Requisition Number: 2301598 Job Category: Regulatory & Compliance Primary Location: Eden Prairie, MN, US (Remote considered) Optum is a global organization that...
Remote WorkAccreditation and Regulatory Compliance Specialist
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 2 days ago
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 2 days ago
Regions Hospital has a great opportunity for an Accreditation and Regulatory Compliance Specialist to join our team. This is a hybrid remote position that will work onsite in Saint Paul weekly....
Regulatory Affairs Specialist II - Ventures (on-site Santa Clara, CA or St. Paul, MN)
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 2 days ago
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 2 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...
A Day in the Life Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the global...
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 3 days ago
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 3 days ago
Our mission is to make higher education accessible and affordable for everyone.** We empower students with financial support and supercharge their ability to pay down their debt, so they can get...
Remote WorkAdvertising Review Compliance Analyst/Senior Analyst/Specialist Hybrid
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 3 days ago
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 3 days ago
What you do: The Advertising Review function delivers and maintains an advertising compliance framework that enables the business and functions to comply with applicable internal and external...
Compliance Analyst, Customer Complaints
- Oakdale, MN (12 miles from Arden Hills, MN)
- 6 days ago
- Oakdale, MN (12 miles from Arden Hills, MN)
- 6 days ago
Compliance Opportunity in Financial Services Compliance Analyst, Customer Complaints Preferred Location(s): 2300 Windy Ridge Parkway, Atlanta, GA 30339 877 Executive Center Drive West, St....
Principal Regulatory Affairs Specialist
- Maple Grove, MN (15 miles from Arden Hills, MN)
- 7 days ago
- Maple Grove, MN (15 miles from Arden Hills, MN)
- 7 days ago
Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring...
Regulatory Affairs Specialist -Peripheral Vascular Health
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 8 days ago
- Minneapolis, MN (7 miles from Arden Hills, MN)
- 8 days ago
Duties and Responsibilities: Collaborate with Operating Unit Regulatory Affairs Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes...
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 9 days ago
- Saint Paul, MN (10 miles from Arden Hills, MN)
- 9 days ago
About Us** Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in...
Demographic Data for Arden Hills, MN
Moving to Arden Hills, MN? Find some basic demographic data about Arden Hills, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Arden Hills, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Arden Hills, 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
- 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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