Regulatory Affairs Specialist Jobs in Loretto, 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
- Plymouth, MN (12 miles from Loretto, MN)
- 9 hours ago
- Plymouth, MN (12 miles from Loretto, MN)
- 9 hours ago
We are currently hiring an International Regulatory Affairs Specialist I to work on-site at our Plymouth, MN location....
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN (12 miles from Loretto, MN)
- 30+ days ago
- Plymouth, MN (12 miles from Loretto, MN)
- 30+ days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
Compliance Analyst - Policy Management and Testing
- Minneapolis, MN (20 miles from Loretto, MN)
- 1 day ago
- Minneapolis, MN (20 miles from Loretto, MN)
- 1 day ago
At U.S. Bank, were on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and...
Senior Product Compliance Analyst
- Chaska, MN (19 miles from Loretto, MN)
- 2 days ago
- Chaska, MN (19 miles from Loretto, MN)
- 2 days ago
Xylem is a Fortune 500 global water solutions company dedicated to advancing sustainable impact and empowering the people who make water work every day. As a leading water technology company with...
- Minneapolis, MN (20 miles from Loretto, MN)
- 4 days ago
- Minneapolis, MN (20 miles from Loretto, MN)
- 4 days ago
We have an exciting opportunity as a Sr. Compliance Analyst to join the team at Ameriprise! In this role you will assist in ensuring communications satisfy regulatory and corporate requirements;...
Sr Regulatory Affairs Specialist (Remote) - Shockwave
- New Brighton, MN (22 miles from Loretto, MN)
- 6 days ago
- New Brighton, MN (22 miles from Loretto, MN)
- 6 days ago
Location: New Brighton, US-MN Rate: Not Specified Type: Permanent Sr Regulatory Affairs Specialist (Remote) - Shockwave At Johnson & Johnson,we believe health is everything....
Remote WorkSr Payroll Tax and Compliance Analyst
- Golden Valley, MN (18 miles from Loretto, MN)
- 9 days ago
- Golden Valley, MN (18 miles from Loretto, MN)
- 9 days ago
Job Duties: Ensure accurate and timely processing of monthly, quarterly, and annual multistate payroll tax filings and payments in compliance with federal, state, and local regulations. Including...
Senior Regulatory Affairs Specialist
- Maple Grove, MN (7 miles from Loretto, MN)
- 10 days ago
- Maple Grove, MN (7 miles from Loretto, MN)
- 10 days ago
About The Role We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position supporting exciting sources of growth for Boston Scientific....
- Minneapolis, MN (20 miles from Loretto, MN)
- 11 days ago
- Minneapolis, MN (20 miles from Loretto, MN)
- 11 days ago
Regulatory Affairs Specialist responsible for reviewing and assessing changes to Class II medical devices, supporting global regulatory compliance, and collaborating with cross-functional teams....
Regulatory Affairs Specialist II
- Maple Grove, MN (7 miles from Loretto, MN)
- 11 days ago
- Maple Grove, MN (7 miles from Loretto, MN)
- 11 days 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...
Cloud Security Risk and Compliance Analyst
- Minneapolis, MN (20 miles from Loretto, MN)
- 13 days ago
- Minneapolis, MN (20 miles from Loretto, MN)
- 13 days ago
At U.S. Bank, were on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and...
Senior Regulatory Affairs Specialist
- Chaska, MN (19 miles from Loretto, MN)
- 15 days ago
- Chaska, MN (19 miles from Loretto, MN)
- 15 days ago
Our client, a leading medical devices manufacturing company, is looking for a Senior Regulatory Affairs Specialist. This is for an initial duration of 18 months and is located in Chaska, MN....
Document Control Records Management - Regulatory Affairs Specialist - Senior
- Chaska, MN (19 miles from Loretto, MN)
- 16 days ago
- Chaska, MN (19 miles from Loretto, MN)
- 16 days ago
Regulatory Affairs Specialist - Senior Job Description: 3 must haves - 1) Experience with design changes, 2) demonstrated RA leadership on high visibility core team, 3) IVDR or EMDR experience The Senior...
Principal Regulatory Affairs Specialist
- Plymouth, MN (12 miles from Loretto, MN)
- 16 days ago
- Plymouth, MN (12 miles from Loretto, MN)
- 16 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 (7 miles from Loretto, MN)
- 16 days ago
- Maple Grove, MN (7 miles from Loretto, MN)
- 16 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...
Demographic Data for Loretto, MN
Moving to Loretto, MN? Find some basic demographic data about Loretto, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Loretto, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Loretto, 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
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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