Regulatory Affairs Specialist Jobs in Shoreview, 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 - Electrophysiology (on-site)
- Plymouth, MN (15 miles from Shoreview, MN)
- 2 days ago
- Plymouth, MN (15 miles from Shoreview, MN)
- 2 days ago
The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in our St. Paul or Plymouth, MN locations....
Principal Regulatory Affairs Specialist - Vascular (on-site)
- Saint Paul, MN (9 miles from Shoreview, MN)
- 9 days ago
- Saint Paul, MN (9 miles from Shoreview, MN)
- 9 days ago
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)....
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN (15 miles from Shoreview, MN)
- 4 hours ago
- Plymouth, MN (15 miles from Shoreview, MN)
- 4 hours ago
Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL...
- Minneapolis, MN (9 miles from Shoreview, MN)
- 5 hours ago
- Minneapolis, MN (9 miles from Shoreview, MN)
- 5 hours ago
Dorsey & Whitney LLP is seeking an associate with two to five years of environmental, natural resources, compliance, or regulatory law experience to join the Regulatory Affairs Practice Group in...
Sr. Compliance Analyst, Employee Benefits
- Minneapolis, MN (9 miles from Shoreview, MN)
- 5 hours ago
- Minneapolis, MN (9 miles from Shoreview, MN)
- 5 hours ago
We are looking to add a Sr. Compliance Analyst to join our Employee Benefits team in Minneapolis, MN ; Waukee, IA ; Kansas City, MO ; or Dallas, TX. Offering a forward-thinking, innovative, and...
Regulatory Affairs Specialist III
- Maple Grove, MN (17 miles from Shoreview, MN)
- 13 hours ago
- Maple Grove, MN (17 miles from Shoreview, MN)
- 13 hours ago
We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position (hybrid work mode) supporting our rapidly growing Left Atrial Appendage Closure (LAAC) device portfolio...
Regulatory Affairs Coordinator
- Eden Prairie, MN (17 miles from Shoreview, MN)
- 1 day ago
- Eden Prairie, MN (17 miles from Shoreview, MN)
- 1 day ago
Shift Start/End Time: 800am - 430pm central - FT hours **start and end time can be flexible The Regulatory Affairs Coordinator Eden Prairie, MN or Telecommuters who are qualified will manage...
Aerospace and Defense Regulatory Affairs Specialist
- Maplewood, MN (7 miles from Shoreview, MN)
- 2 days ago
- Maplewood, MN (7 miles from Shoreview, MN)
- 2 days ago
Job Description: Job Title Aerospace and Defense Regulatory Affairs Specialist Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your...
Principal Regulatory Affairs Specialist
- Maple Grove, MN (17 miles from Shoreview, MN)
- 2 days ago
- Maple Grove, MN (17 miles from Shoreview, MN)
- 2 days ago
About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division....
Senior Regulatory Affairs Specialist
- Minneapolis, MN (9 miles from Shoreview, MN)
- 3 days ago
- Minneapolis, MN (9 miles from Shoreview, MN)
- 3 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
Sr. Business System Compliance Analyst
- Plymouth, MN (15 miles from Shoreview, MN)
- 7 days ago
- Plymouth, MN (15 miles from Shoreview, MN)
- 7 days ago
Abbott Sr. Business System Compliance Analyst in Plymouth , Minnesota Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing...
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
- New Brighton, MN (2 miles from Shoreview, MN)
- 7 days ago
- New Brighton, MN (2 miles from Shoreview, MN)
- 7 days ago
Support and comply with the company's Quality Management System policies and procedures. Ability to act with an inclusion mindset and model these behaviors for the organization....
Remote WorkRemote IT Quality Assurance and Compliance, Analyst
- Saint Paul, MN (9 miles from Shoreview, MN)
- 8 days ago
- Saint Paul, MN (9 miles from Shoreview, MN)
- 8 days ago
Carrington Remote IT Quality Assurance and Compliance, Analyst in Saint Paul , Minnesota Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and...
Remote WorkCompliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Saint Paul, MN (9 miles from Shoreview, MN)
- 12 days ago
- Saint Paul, MN (9 miles from Shoreview, MN)
- 12 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. Job Posting Title...
Remote WorkPrincipal Regulatory Affairs Specialist - Hybrid
- Minneapolis, MN (9 miles from Shoreview, MN)
- 16 days ago
- Minneapolis, MN (9 miles from Shoreview, MN)
- 16 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....
Demographic Data for Shoreview, MN
Moving to Shoreview, MN? Find some basic demographic data about Shoreview, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Shoreview, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Shoreview, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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