Regulatory Affairs Specialist Jobs in Lakeville, 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.
Senior Regulatory Affairs Specialist - Cardiac Surgery
- Minneapolis, MN (24 miles from Lakeville, MN)
- 5 hours ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 5 hours ago
., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting (CABG) solutions The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies...
Associate Regulatory Affairs Specialist
- Minneapolis, MN (24 miles from Lakeville, MN)
- 5 hours ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 5 hours ago
The Associate Regulatory Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support for Cardiac Surgery products....
Regulatory Affairs Specialist - Cardiac Surgery
- Minneapolis, MN (24 miles from Lakeville, MN)
- 5 hours ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 5 hours ago
Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these...
- Minneapolis, MN (24 miles from Lakeville, MN)
- 1 day ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 1 day ago
Dorsey & Whitney LLP is seeking an associate with two to five years of environmental, natural resources, compliance, or regulatory law experience to join the Regulatory Affairs Practice Group in...
Sr. Compliance Analyst, Employee Benefits
- Minneapolis, MN (24 miles from Lakeville, MN)
- 1 day ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 1 day ago
We are looking to add a Sr. Compliance Analyst to join our Employee Benefits team in Minneapolis, MN ; Waukee, IA ; Kansas City, MO ; or Dallas, TX. Offering a forward-thinking, innovative, and...
Senior Regulatory Affairs Specialist
- Minneapolis, MN (24 miles from Lakeville, MN)
- 4 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 4 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
Remote IT Quality Assurance and Compliance, Analyst
- Saint Paul, MN (24 miles from Lakeville, MN)
- 9 days ago
- Saint Paul, MN (24 miles from Lakeville, MN)
- 9 days ago
Carrington Remote IT Quality Assurance and Compliance, Analyst in Saint Paul , Minnesota Come join our amazing team and work remote from home! What you'll do: Responsible for the timely and...
Remote WorkPrincipal Regulatory Affairs Specialist - Vascular (on-site)
- Saint Paul, MN (24 miles from Lakeville, MN)
- 10 days ago
- Saint Paul, MN (24 miles from Lakeville, MN)
- 10 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)....
Compliance Analyst Sr--Medical Pharmacy Specialty/Medicare Part B- REMOTE
- Saint Paul, MN (24 miles from Lakeville, MN)
- 13 days ago
- Saint Paul, MN (24 miles from Lakeville, MN)
- 13 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. Job Posting Title...
Remote WorkPrincipal Regulatory Affairs Specialist - Hybrid
- Minneapolis, MN (24 miles from Lakeville, MN)
- 17 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 17 days ago
Supports internal audits and external inspections. Assists team members to support worldwide licenses and registrations as needed. Monitors and improves tracking/control systems....
- Saint Paul, MN (24 miles from Lakeville, MN)
- 27 days ago
- Saint Paul, MN (24 miles from Lakeville, MN)
- 27 days ago
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation...
Sr Substation Compliance Analyst
- Minneapolis, MN (24 miles from Lakeville, MN)
- 29 days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 29 days ago
The primary responsibility of this position is the daily management and administration of Substation processes and documentation required to support the Xcel Energy regulatory oversight and...
Medical Affairs Compliance Analyst Sr
- Eagan, MN (18 miles from Lakeville, MN)
- 30+ days ago
- Eagan, MN (18 miles from Lakeville, MN)
- 30+ days ago
About Blue Cross and Blue Shield of Minnesota At Blue Cross and Blue Shield of Minnesota, we are committed to paving the way for everyone to achieve their healthiest life. We are looking for...
Senior Regulatory Affairs Specialists
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
Ensure product adherence to government and industry standards including Quality System Regulation (QSR 21 CFR 820), ASEAN Medical Device Directive (AMDD), CMDR, ISO 13485 and ISO 14971....
Sr Regulatory Compliance Specialist
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
- Minneapolis, MN (24 miles from Lakeville, MN)
- 30+ days ago
Rise Baking Company was founded by bakery experts passionate about providing our customers with high quality products and providing a positive, collaborative place to work for our people. We are a...
Demographic Data for Lakeville, MN
Moving to Lakeville, MN? Find some basic demographic data about Lakeville, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Lakeville, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Lakeville, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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