Regulatory Affairs Specialist Jobs in Waconia, 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.
International Regulatory Affairs Specialist I - Medical Devices (onsite)
- Plymouth, MN (19 miles from Waconia, MN)
- 9 days ago
- Plymouth, MN (19 miles from Waconia, MN)
- 9 days ago
We are currently hiring an International Regulatory Affairs Specialist I to work on-site at our Plymouth, MN location....
Senior Regulatory Affairs Specialist
- Minnetonka, MN (18 miles from Waconia, MN)
- 6 hours ago
- Minnetonka, MN (18 miles from Waconia, MN)
- 6 hours ago
regulations, ISO standards, and other regulatory agencies....
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN (19 miles from Waconia, MN)
- 2 days ago
- Plymouth, MN (19 miles from Waconia, MN)
- 2 days 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...
Regulatory Affairs Specialist III
- Maple Grove, MN (22 miles from Waconia, MN)
- 2 days ago
- Maple Grove, MN (22 miles from Waconia, MN)
- 2 days 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...
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN (19 miles from Waconia, MN)
- 5 days ago
- Plymouth, MN (19 miles from Waconia, MN)
- 5 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
- Maple Grove, MN (22 miles from Waconia, MN)
- 5 days ago
- Maple Grove, MN (22 miles from Waconia, MN)
- 5 days ago
About the role: We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Peripheral Interventions Division....
Sr. Business System Compliance Analyst
- Plymouth, MN (19 miles from Waconia, MN)
- 9 days ago
- Plymouth, MN (19 miles from Waconia, MN)
- 9 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...
Senior Regulatory Affairs Specialist (on-site)
- Plymouth, MN (19 miles from Waconia, MN)
- 30+ days ago
- Plymouth, MN (19 miles from Waconia, MN)
- 30+ days ago
The Opportunity Abbott is seeking a passionate, experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, MN....
Senior Regulatory Affairs Specialist
- Plymouth, MN (19 miles from Waconia, MN)
- 30+ days ago
- Plymouth, MN (19 miles from Waconia, MN)
- 30+ days ago
Specialized Knowledge: Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all applicable laws which regulate medical device manufacturers....
- Chanhassen, MN (10 miles from Waconia, MN)
- 45+ days ago
- Chanhassen, MN (10 miles from Waconia, MN)
- 45+ days ago
Internal Audit Department Support: Support the Internal Audit team in other compliance-related tasks as needed....
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN (19 miles from Waconia, MN)
- 60+ days ago
- Plymouth, MN (19 miles from Waconia, MN)
- 60+ days 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...
Demographic Data for Waconia, MN
Moving to Waconia, MN? Find some basic demographic data about Waconia, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Waconia, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Waconia, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Lean Six Sigma
- 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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