Regulatory Affairs Specialist Jobs in Elk River, 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
- Maple Grove, MN (14 miles from Elk River, MN)
- 10 hours ago
- Maple Grove, MN (14 miles from Elk River, MN)
- 10 hours ago
Participate in development and implementation of departmental policies and procedures Foster a work environment of continuous improvement that supports BSCs Quality Policy, Quality System and the appropriate...
Principal Regulatory Affairs Specialist
- Plymouth, MN (23 miles from Elk River, MN)
- 5 days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 5 days ago
You have expertise in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations....
Regulatory Affairs Specialist - Medical Devices
- Maple Grove, MN (14 miles from Elk River, MN)
- 5 days ago
- Maple Grove, MN (14 miles from Elk River, MN)
- 5 days ago
Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Specialist will lead and execute regulatory submission and approval activities for the company's medical device products, with...
Sr Prncpl Intl Trade Compliance Analyst
- Plymouth, MN (23 miles from Elk River, MN)
- 6 days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 6 days ago
RELOCATION ASSISTANCE: No relocation assistance available CLEARANCE TYPE: Secret TRAVEL: Yes, 10% of the Time **Description** At Northrop Grumman, our employees have incredible opportunities to...
Senior Regulatory Affairs Specialist - Peripheral Interventions
- Maple Grove, MN (14 miles from Elk River, MN)
- 13 days ago
- Maple Grove, MN (14 miles from Elk River, MN)
- 13 days ago
The Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations...
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN (23 miles from Elk River, MN)
- 26 days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 26 days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
Principal Regulatory Affairs Specialist Electrophysiology (on-site)
- Plymouth, MN (23 miles from Elk River, MN)
- 30+ days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 30+ 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)
- Plymouth, MN (23 miles from Elk River, MN)
- 30+ days ago
- Plymouth, MN (23 miles from Elk River, MN)
- 30+ 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 Elk River, MN
Moving to Elk River, MN? Find some basic demographic data about Elk River, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Elk River, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Elk River, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Consulting
- Environmental Compliance
- Geotechnical Engineering
- Civil Engineering
- Internal Audits
- 21 CFR 820
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Data Entry
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Multitasking
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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