Regulatory Affairs Specialist Jobs in Hamel, 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 (8 miles from Hamel, MN)
- 30+ days ago
- Plymouth, MN (8 miles from Hamel, 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....
Sr Regulatory Affairs Specialist (Remote) - Shockwave
- New Brighton, MN (19 miles from Hamel, MN)
- 20 hours ago
- New Brighton, MN (19 miles from Hamel, MN)
- 20 hours 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 Work- Brooklyn Park, MN (9 miles from Hamel, MN)
- 1 day ago
- Brooklyn Park, MN (9 miles from Hamel, MN)
- 1 day ago
Pay Range: $75,000 - $80,000 Location: Ideally seated at one of our major facilities in: Brooklyn Park, MN Greenwood, IN Roanoke, VA Sanford, FL Bondurant, IA Willing to consider remote...
Principal Regulatory Affairs Specialist
- Maple Grove, MN (4 miles from Hamel, MN)
- 1 day ago
- Maple Grove, MN (4 miles from Hamel, MN)
- 1 day ago
Systems standards Prior experience with a variety of regulatory submissions for US and EU MDR Previous experience interacting with regulators and leading initiatives across functions, divisions, or...
- Bloomington, MN (22 miles from Hamel, MN)
- 1 day ago
- Bloomington, MN (22 miles from Hamel, MN)
- 1 day ago
HealthPartners is currently hiring for a Benefits Compliance Analyst. The analyst ensures that HealthPartners remains compliant with the Affordable Care Act (ACA) and other regulatory requirements...
Regulatory Operations Specialist
- Minneapolis, MN (16 miles from Hamel, MN)
- 1 day ago
- Minneapolis, MN (16 miles from Hamel, MN)
- 1 day ago
Strong understanding of FDA regulations related to medical device registration and listing....
Sr Payroll Tax and Compliance Analyst
- Golden Valley, MN (14 miles from Hamel, MN)
- 3 days ago
- Golden Valley, MN (14 miles from Hamel, MN)
- 3 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....
Senior Regulatory Affairs Specialist
- Maple Grove, MN (4 miles from Hamel, MN)
- 4 days ago
- Maple Grove, MN (4 miles from Hamel, MN)
- 4 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....
Regulatory Affairs Specialist - ACM
- Mounds View, MN (19 miles from Hamel, MN)
- 4 days ago
- Mounds View, MN (19 miles from Hamel, MN)
- 4 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
- Minneapolis, MN (16 miles from Hamel, MN)
- 5 days ago
- Minneapolis, MN (16 miles from Hamel, MN)
- 5 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 (4 miles from Hamel, MN)
- 5 days ago
- Maple Grove, MN (4 miles from Hamel, MN)
- 5 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 (16 miles from Hamel, MN)
- 7 days ago
- Minneapolis, MN (16 miles from Hamel, MN)
- 7 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 (18 miles from Hamel, MN)
- 9 days ago
- Chaska, MN (18 miles from Hamel, MN)
- 9 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....
Compliance Analyst (R25_0000002183)
- Minneapolis, MN (16 miles from Hamel, MN)
- 9 days ago
- Minneapolis, MN (16 miles from Hamel, MN)
- 9 days ago
We are searching for a Compliance Analyst within the General Counsel's Organization team, who is a hardworking self-starter motivated by achieving and exceeding goals who will support the...
Document Control Records Management - Regulatory Affairs Specialist - Senior
- Chaska, MN (18 miles from Hamel, MN)
- 10 days ago
- Chaska, MN (18 miles from Hamel, MN)
- 10 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...
Demographic Data for Hamel, MN
Moving to Hamel, MN? Find some basic demographic data about Hamel, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hamel, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hamel, 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
- Cross-Functional Team Management
- Internal Control
- Management Reporting
- Reimbursement
- 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
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Education Experience
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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