Regulatory Affairs Specialist Jobs in Hopkins, 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 Coordinator
- Saint Paul, MN (17 miles from Hopkins, MN)
- 3 days ago
- Saint Paul, MN (17 miles from Hopkins, MN)
- 3 days ago
Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments....
- Saint Paul, MN (17 miles from Hopkins, MN)
- 1 day ago
- Saint Paul, MN (17 miles from Hopkins, MN)
- 1 day 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)...
Associate Regulatory Affairs Specialist - Cardiac Surgery
- Minneapolis, MN (8 miles from Hopkins, MN)
- 1 day ago
- Minneapolis, MN (8 miles from Hopkins, MN)
- 1 day ago
A Day in the Life This role will be onsite in Mounds View, MN The Associate Regulatory Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support...
Principal Regulatory Affairs Specialist
- Eden Prairie, MN (2 miles from Hopkins, MN)
- 3 days ago
- Eden Prairie, MN (2 miles from Hopkins, MN)
- 3 days ago
Principal Regulatory Affairs Specialist LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies?...
- Minneapolis, MN (8 miles from Hopkins, MN)
- 5 days ago
- Minneapolis, MN (8 miles from Hopkins, MN)
- 5 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 (8 miles from Hopkins, MN)
- 5 days ago
- Minneapolis, MN (8 miles from Hopkins, MN)
- 5 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...
Senior Regulatory Affairs Specialist (Solventum)
- Saint Paul, MN (17 miles from Hopkins, MN)
- 7 days ago
- Saint Paul, MN (17 miles from Hopkins, MN)
- 7 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....
Sr. Cyber Security Compliance Analyst Remote, USA
- Minneapolis, MN (8 miles from Hopkins, MN)
- 7 days ago
- Minneapolis, MN (8 miles from Hopkins, MN)
- 7 days ago
This position is responsible for leading the collection and analysis of key performance metrics, conducting internal audits and assessments, leading third-party risk assessments, and internal risk management...
Remote Work- Saint Paul, MN (17 miles from Hopkins, MN)
- 7 days ago
- Saint Paul, MN (17 miles from Hopkins, MN)
- 7 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...
Principal Regulatory Affairs Specialist - Hybrid
- Minneapolis, MN (8 miles from Hopkins, MN)
- 8 days ago
- Minneapolis, MN (8 miles from Hopkins, MN)
- 8 days ago
Supports internal audits and external inspections. Assists team members to support worldwide licenses and registrations as needed. Monitors and improves tracking/control systems....
- Bloomington, MN (11 miles from Hopkins, MN)
- 9 days ago
- Bloomington, MN (11 miles from Hopkins, MN)
- 9 days ago
Security Compliance Analyst#25-13246 Bloomington, MN Fully Remote Contract Starts 4/28/2025 Ends 1/14/2026 Job Description Genesis10 is currently looking for a Security Compliance Analyst for an...
Remote Work- Minneapolis, MN (8 miles from Hopkins, MN)
- 9 days ago
- Minneapolis, MN (8 miles from Hopkins, MN)
- 9 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...
- Saint Paul, MN (17 miles from Hopkins, MN)
- 15 days ago
- Saint Paul, MN (17 miles from Hopkins, MN)
- 15 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 enda way to help us meet the bottom line. UMB isn't comprised of workers, but of people who...
- Bloomington, MN (11 miles from Hopkins, MN)
- 16 days ago
- Bloomington, MN (11 miles from Hopkins, MN)
- 16 days ago
SOC 2 Compliance Analyst#25-13246 Bloomington, MN Fully Remote Contract Starts 4/14/2025 Ends 1/14/2026 Job Description Genesis10 is currently looking for a SOC 2 Compliance Analyst for an 8 month...
Remote WorkSenior Regulatory Affairs Specialist
- Burnsville, MN (16 miles from Hopkins, MN)
- 17 days ago
- Burnsville, MN (16 miles from Hopkins, MN)
- 17 days ago
Support company compliance, including practical guidance and expertise with quality management system regulations....
Demographic Data for Hopkins, MN
Moving to Hopkins, MN? Find some basic demographic data about Hopkins, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hopkins, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hopkins, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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