Regulatory Affairs Specialist Jobs in Buffalo, 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 (23 miles from Buffalo, MN)
- 11 days ago
- Plymouth, MN (23 miles from Buffalo, MN)
- 11 days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
- Wayzata, MN (21 miles from Buffalo, MN)
- 2 days ago
- Wayzata, MN (21 miles from Buffalo, MN)
- 2 days ago
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...
Principal Regulatory Affairs Specialist Electrophysiology (on-site)
- Plymouth, MN (23 miles from Buffalo, MN)
- 23 days ago
- Plymouth, MN (23 miles from Buffalo, 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
- Maple Grove, MN (17 miles from Buffalo, MN)
- 24 days ago
- Maple Grove, MN (17 miles from Buffalo, MN)
- 24 days 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...
Principal Regulatory Affairs Specialist Electrophysiology (on-site)
- Plymouth, MN (23 miles from Buffalo, MN)
- 25 days ago
- Plymouth, MN (23 miles from Buffalo, MN)
- 25 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 Buffalo, MN
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Buffalo, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Buffalo, 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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