Regulatory Affairs Specialist Jobs in Anoka, 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 Operations Specialist - Cardiac Rhythm Management
- Mounds View, MN (18 miles from Anoka, MN)
- 20 hours ago
- Mounds View, MN (18 miles from Anoka, MN)
- 20 hours ago
We anticipate the application window for this opening will close on - 19 May 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare...
Associate Regulatory Operations Specialist - Cardiac Rhythm Management
- Mounds View, MN (18 miles from Anoka, MN)
- 20 hours ago
- Mounds View, MN (18 miles from Anoka, MN)
- 20 hours ago
We anticipate the application window for this opening will close on - 19 May 2025 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare...
Senior Regulatory Affairs Specialist - ACM
- Mounds View, MN (18 miles from Anoka, MN)
- 5 days ago
- Mounds View, MN (18 miles from Anoka, MN)
- 5 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 (21 miles from Anoka, MN)
- 7 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 7 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...
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Principal Regulatory Affairs Specialist - Electrophysiology
- Arden Hills, MN (18 miles from Anoka, MN)
- 9 days ago
- Arden Hills, MN (18 miles from Anoka, MN)
- 9 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 (22 miles from Anoka, MN)
- 12 days ago
- Little Canada, MN (22 miles from Anoka, MN)
- 12 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 (21 miles from Anoka, MN)
- 12 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 12 days ago
audits....
- Minneapolis, MN (21 miles from Anoka, MN)
- 12 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 12 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 (21 miles from Anoka, MN)
- 12 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 12 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 (21 miles from Anoka, MN)
- 14 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 14 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 (21 miles from Anoka, MN)
- 16 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 16 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...
Regulatory Compliance Specialist
- Rogers, MN (10 miles from Anoka, MN)
- 19 days ago
- Rogers, MN (10 miles from Anoka, MN)
- 19 days ago
North Star Imaging (NSI), a global leader in 2D digital radiography and 3D computed tomography equipment, is part of Illinois Tool Works (ITW), a Fortune 250 company. We offer an engaging work...
- Minneapolis, MN (21 miles from Anoka, MN)
- 28 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 28 days ago
Pay Range- $42/hr. -$45hr. Theyre looking for an experienced regulatory affairs professional who can independently manage post-market submissions assess changes, and collaborate across teams....
Senior Compliance Analyst (R25_0000000223)
- Minneapolis, MN (21 miles from Anoka, MN)
- 28 days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 28 days ago
We have an exciting opportunity as a Senior Compliance Analyst at Ameriprise! In this role you will assist in ensuring communications satisfy regulatory and corporate requirements; support...
- Minneapolis, MN (21 miles from Anoka, MN)
- 30+ days ago
- Minneapolis, MN (21 miles from Anoka, MN)
- 30+ days ago
Regulatory Affairs Specialist is responsible for creating and assuring compliance of federally regulated product label information, including nutrition, ingredient declaration, allergens, claims and...
Demographic Data for Anoka, MN
Moving to Anoka, MN? Find some basic demographic data about Anoka, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Anoka, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Anoka, 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
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- 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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