Regulatory Affairs Specialist Jobs in Otsego, 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 (20 miles from Otsego, MN)
- 45+ days ago
- Plymouth, MN (20 miles from Otsego, MN)
- 45+ days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
Investment Reporting and Compliance Analyst (Hybrid)
- Plymouth, MN (20 miles from Otsego, MN)
- 2 days ago
- Plymouth, MN (20 miles from Otsego, MN)
- 2 days ago
Our employees are at the heart of what we do: helping people, businesses and society prosper in good times and be resilient in bad times. When you join our team, you are bringing this purpose to...
Principal Regulatory Affairs Specialist
- Maple Grove, MN (12 miles from Otsego, MN)
- 8 days ago
- Maple Grove, MN (12 miles from Otsego, MN)
- 8 days ago
Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring...
Senior Regulatory Affairs Specialist (on-site)
- Plymouth, MN (20 miles from Otsego, MN)
- 18 days ago
- Plymouth, MN (20 miles from Otsego, MN)
- 18 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
- Maple Grove, MN (12 miles from Otsego, MN)
- 30+ days ago
- Maple Grove, MN (12 miles from Otsego, MN)
- 30+ 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 II
- Maple Grove, MN (12 miles from Otsego, MN)
- 30+ days ago
- Maple Grove, MN (12 miles from Otsego, MN)
- 30+ days ago
This Regulatory Affairs Specialist II role will be a part of the Interventional Cardiology Regulatory Affairs team and will be supporting regulatory submission activities to obtain and maintain regulatory...
Regulatory Affairs Specialist - Medical Devices
- Maple Grove, MN (12 miles from Otsego, MN)
- 30+ days ago
- Maple Grove, MN (12 miles from Otsego, MN)
- 30+ 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...
Senior Regulatory Affairs Specialist - Peripheral Interventions
- Maple Grove, MN (12 miles from Otsego, MN)
- 45+ days ago
- Maple Grove, MN (12 miles from Otsego, MN)
- 45+ 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...
Principal Regulatory Affairs Specialist Electrophysiology (on-site)
- Plymouth, MN (20 miles from Otsego, MN)
- 60+ days ago
- Plymouth, MN (20 miles from Otsego, MN)
- 60+ 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 Otsego, MN
Moving to Otsego, MN? Find some basic demographic data about Otsego, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Otsego, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Otsego, 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
- Internal Control
- Management Reporting
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Continuous Improvement
- Product Development
- Engineering
- Risk Management
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Written Communication
- Education Experience
- Investigation
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »