Regulatory Affairs Specialist Jobs in Wayzata, 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 (6 miles from Wayzata, MN)
- 10 days ago
- Plymouth, MN (6 miles from Wayzata, MN)
- 10 days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
Regulatory Affairs Associate (#956) - Minneapolis
- Minneapolis, MN (13 miles from Wayzata, MN)
- 1 day ago
- Minneapolis, MN (13 miles from Wayzata, MN)
- 1 day ago
Regulatory Affairs Associate (#956) - Minneapolis Dorsey & Whitney LLP - 3.8 Minneapolis, MN Job Details $210,000 - $265,000 a year 17 hours ago Benefits Travel reimbursement Paid parental leave...
- Minneapolis, MN (13 miles from Wayzata, MN)
- 1 day ago
- Minneapolis, MN (13 miles from Wayzata, MN)
- 1 day ago
Avenica is a Talent Partner of Walser Automotive Group, helping to launch dynamic careers for talent across all departments at Walser stores. We're evaluating talent for a proactive, detail-savvy,...
POSITION SUMMARY: The Compliance Analyst supports the Company by fulfilling its corporate requirements regarding licensing and reporting to state and/or federal departments. This position is...
Regulatory Compliance Specialist
- Minneapolis, MN (13 miles from Wayzata, MN)
- 4 days ago
- Minneapolis, MN (13 miles from Wayzata, MN)
- 4 days ago
Regulatory Compliance Specialist BlueCross BlueShield of South Carolina life insurance, paid time off, tuition assistance, 401(k) United States, Minnesota, Minneapolis Jun 07, 2025 Summary The...
- Minneapolis, MN (13 miles from Wayzata, MN)
- 4 days ago
- Minneapolis, MN (13 miles from Wayzata, MN)
- 4 days ago
A Day in the Life SENIOR REGULATORY AFFAIRS SPECIALIST In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology...
- Eagan, MN (20 miles from Wayzata, MN)
- 6 days ago
- Eagan, MN (20 miles from Wayzata, MN)
- 6 days ago
External Compliance Analyst Blue Cross Blue Shield of Minnesota - 3.7 Eagan, MN Job Details Full-time $67,200 - $111,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid...
Regulatory Affairs Specialist - Post Market
- Saint Paul, MN (22 miles from Wayzata, MN)
- 7 days ago
- Saint Paul, MN (22 miles from Wayzata, MN)
- 7 days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkSenior Data & Compliance Analyst
- Saint Paul, MN (22 miles from Wayzata, MN)
- 8 days ago
- Saint Paul, MN (22 miles from Wayzata, MN)
- 8 days ago
Senior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
Compliance Analyst/ Compliance Analyst Senior Hybrid
- Minneapolis, MN (13 miles from Wayzata, MN)
- 10 days ago
- Minneapolis, MN (13 miles from Wayzata, MN)
- 10 days ago
He/She will also support direct regulatory requests, market conduct exams and internal audit requests....
Compliance Analyst/ Compliance Analyst Senior - Financial Crimes Unit/AML Hybrid
- Minneapolis, MN (13 miles from Wayzata, MN)
- 12 days ago
- Minneapolis, MN (13 miles from Wayzata, MN)
- 12 days ago
The Ethics & Compliance Analyst will be focused on supporting the Company's Anti-Money Laundering & Economic Sanctions Programs, and will report to the AML, Sanctions, and Agent Oversight Manager....
Senior Regulatory Affairs Specialist (Remote - USA)
- Saint Paul, MN (22 miles from Wayzata, MN)
- 13 days ago
- Saint Paul, MN (22 miles from Wayzata, MN)
- 13 days ago
Job Description: Senior Regulatory Affairs Specialist (Remote - USA) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives....
Remote WorkREMOTE Part Time Sr Regulatory Affairs Specialist
- Minneapolis, MN (13 miles from Wayzata, MN)
- 18 days ago
- Minneapolis, MN (13 miles from Wayzata, MN)
- 18 days ago
Close REMOTE Part Time Sr Regulatory Affairs Specialist Minneapolis, Minnesota Mechanical Engineering 258 days ago Apply Job Summary: Responsible for managing regulatory compliance for product modifications...
Remote WorkPrincipal Regulatory Affairs Specialist Electrophysiology (on-site)
- Plymouth, MN (6 miles from Wayzata, MN)
- 23 days ago
- Plymouth, MN (6 miles from Wayzata, MN)
- 23 days ago
Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time...
Principal Regulatory Affairs Specialist - Electrophysiology (on-site)
- Saint Paul, MN (22 miles from Wayzata, MN)
- 23 days ago
- Saint Paul, MN (22 miles from Wayzata, MN)
- 23 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)....
Demographic Data for Wayzata, MN
Moving to Wayzata, MN? Find some basic demographic data about Wayzata, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Wayzata, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Wayzata, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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