Regulatory Affairs Specialist Jobs in Fridley, 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.
Senior Regulatory Affairs Specialist (Solventum)
- Eden Prairie, MN (12 miles from Fridley, MN)
- 1 day ago
- Eden Prairie, MN (12 miles from Fridley, MN)
- 1 day 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....
Regulatory Affairs Specialist II
- Saint Paul, MN (10 miles from Fridley, MN)
- 4 hours ago
- Saint Paul, MN (10 miles from Fridley, MN)
- 4 hours 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...
Senior Regulatory Affairs Specialist - Cardiac Surgery
- Minneapolis, MN (4 miles from Fridley, MN)
- 1 day ago
- Minneapolis, MN (4 miles from Fridley, MN)
- 1 day ago
A Day in the Life The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for...
Regulatory Affairs Coordinator
- Eden Prairie, MN (12 miles from Fridley, MN)
- 3 days ago
- Eden Prairie, MN (12 miles from Fridley, MN)
- 3 days ago
Are you someone who loves to be an integral part of everyday business? If so, look no further and apply below for an opportunity to join a global organization that delivers care! Adecco is...
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- Eagan, MN (13 miles from Fridley, MN)
- 4 days ago
- Eagan, MN (13 miles from Fridley, MN)
- 4 days ago
Starting Salary Range: $80,000-96,000 - position is also eligible for an annual bonus if individual performance and company objectives are met. In one year as our Compliance Analyst, you will know...
Senior Regulatory Affairs Associate
- Maplewood, MN (11 miles from Fridley, MN)
- 4 days ago
- Maplewood, MN (11 miles from Fridley, MN)
- 4 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...
Senior Regulatory Affairs Specialist - ACM
- Mounds View, MN (3 miles from Fridley, MN)
- 4 days ago
- Mounds View, MN (3 miles from Fridley, MN)
- 4 days ago
A Day in the Life We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM)....
- Minneapolis, MN (4 miles from Fridley, MN)
- 6 days ago
- Minneapolis, MN (4 miles from Fridley, MN)
- 6 days ago
, a division of UMB Bank n.a. Are you ready to be part of something more? You're more than a means to an end-a way to help us meet the bottom line. UMB isn't comprised of workers, but of people...
Principal Regulatory Affairs Specialist - Electrophysiology
- Arden Hills, MN (3 miles from Fridley, MN)
- 8 days ago
- Arden Hills, MN (3 miles from Fridley, MN)
- 8 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 I
- Little Canada, MN (5 miles from Fridley, MN)
- 11 days ago
- Little Canada, MN (5 miles from Fridley, MN)
- 11 days 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...
Senior Trade Compliance Analyst
- Minneapolis, MN (4 miles from Fridley, MN)
- 11 days ago
- Minneapolis, MN (4 miles from Fridley, MN)
- 11 days ago
audits....
- Minneapolis, MN (4 miles from Fridley, MN)
- 11 days ago
- Minneapolis, MN (4 miles from Fridley, MN)
- 11 days ago
Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes. Design, develop, test, document & support of cGxP systems as per 21CFR Part11 & US FDA....
AIM Governance, Risk, Compliance Analyst Senior Hybrid
- Minneapolis, MN (4 miles from Fridley, MN)
- 11 days ago
- Minneapolis, MN (4 miles from Fridley, MN)
- 11 days ago
At Allianz Life, we are driven by our mission - we secure your future - and by our common goal of caring for tomorrow. We care for our employees by promoting an inclusive culture where everyone...
- Minneapolis, MN (4 miles from Fridley, MN)
- 13 days ago
- Minneapolis, MN (4 miles from Fridley, MN)
- 13 days ago
Utilities Compliance Analyst 3.6 3.6 out of 5 stars Minneapolis, MN 55401 System One is actively recruiting for a Utilities Compliance Analyst for a long-term contract position located in...
Licensing and Regulatory Compliance Analyst
- Minneapolis, MN (4 miles from Fridley, MN)
- 15 days ago
- Minneapolis, MN (4 miles from Fridley, MN)
- 15 days ago
Licensing and Regulatory Compliance Analyst Full-time Company Description We're the world's leading sports technology company, at the intersection between sports, media, and betting. More than...
Demographic Data for Fridley, MN
Moving to Fridley, MN? Find some basic demographic data about Fridley, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fridley, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fridley, 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
- 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
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- 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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