Regulatory Affairs Specialist Jobs in Minnesota
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.
Summary: Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and...
In PersonA Day in the Life The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio....
In PersonPrincipal Regulatory Affairs Specialist
- Medtronic
- Mounds View, MN
- 14 days ago
- Mounds View, MN
- 14 days ago
The Principal Regulatory Affairs Specialist will provide strategic leadership for regulatory affairs in support of new product development and introduction within Medtronics Structural Heart Operating...
In PersonTrade Compliance Analyst (USMCA) - The Toro Company
- Toro Company
- Bloomington, MN
- 15 days ago
- Bloomington, MN
- 15 days ago
Who Are We? The Toro Company is a homegrown, Minnesota-based company that has been in business since 1914. We pride ourselves on providing world-class equipment to help maintain the environment...
Remote HybridCheck us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions The Principal Regulatory Affairs Specialist (Pr....
In PersonRegulatory Affairs Specialist (Submissions Focus) Experience Level: 2-5 Years Role Overview We are seeking a driven Regulatory Affairs Specialist to spearhead our global market access strategy....
In PersonRemote Retirement Plan Compliance Analyst
- Ascensus
- Minneapolis, MN
- 19 days ago
- Minneapolis, MN
- 19 days ago
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch...
RemoteAt Northmarq, you can be part of something special. Northmarq is a unique capital markets resource for commercial real estate investors, providing our clients access to experts in debt, equity,...
In PersonRegulatory Affairs Specialist - Global Markets
- MED Medtronic Inc
- Rice, MN
- 20 days ago
- Rice, MN
- 20 days ago
Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide submissions for high-risk medical devices....
In PersonLabeling and Regulatory Compliance Specialist
- Dahl Consulting
- Golden Valley, MN
- 21 days ago
- Golden Valley, MN
- 21 days ago
Title : Labeling and Regulatory Compliance Specialist Location : Remote Job Type : Contract (12 Months) Compensation : $30 - $49/hr Schedule: Monday Friday, 37.5 hours per week (Start time 7-8am...
RemoteSenior Regulatory Affairs Specialist- Product Development
- Demant
- Eden Prairie, MN
- 21 days ago
- Eden Prairie, MN
- 21 days ago
We looking for an experienced Senior Regulatory Affairs Specialist-Product Development....
HybridJob Purpose: Provides complex analysis, daily operational execution, and monitoring of company's trade compliance programs, policies, procedures and internal audit programs to ensure compliance with...
HybridRegulatory Affairs Specialist II
- Stereotaxis
- Minneapolis, MN
- 30+ days ago
- Minneapolis, MN
- 30+ days ago
Position Summary: The Regulatory Affairs Specialist II provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory...
In PersonPrincipal Regulatory Affairs Spec ; Pelvic Health
- MED Medtronic Inc
- Rice, MN
- 30+ days ago
- Rice, MN
- 30+ days ago
Role Overview The Principal Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide clinical trial applications for high-risk medical devices....
In PersonPrincipal Regulatory Affairs Spec ; Pelvic Health
- Medtronic
- Minneapolis, MN
- 30+ days ago
- Minneapolis, MN
- 30+ days ago
Role Overview The Principal Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide clinical trial applications for high-risk medical devices....
In PersonDemographic Data for Minnesota
Moving to Minnesota? Find some basic demographic data about Minnesota below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Minnesota
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Minnesota offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Systems Applications & Products
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Sales
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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