Regulatory Affairs Specialist Jobs in Brooklyn Center, 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.
- Medtronic Inc.
- Mounds View, MN (9 miles from Brooklyn Center, MN)
- 12 days ago
- Mounds View, MN (9 miles from Brooklyn Center, MN)
- 12 days ago
A 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 (9 miles from Brooklyn Center, MN)
- 14 days ago
- Mounds View, MN (9 miles from Brooklyn Center, 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 (16 miles from Brooklyn Center, MN)
- 15 days ago
- Bloomington, MN (16 miles from Brooklyn Center, 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 Hybrid- Planet Pharma Group
- Eagan, MN (17 miles from Brooklyn Center, MN)
- 18 days ago
- Eagan, MN (17 miles from Brooklyn Center, MN)
- 18 days ago
Regulatory 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 (7 miles from Brooklyn Center, MN)
- 19 days ago
- Minneapolis, MN (7 miles from Brooklyn Center, 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...
Remote- NorthMarq Capital
- Minneapolis, MN (7 miles from Brooklyn Center, MN)
- 19 days ago
- Minneapolis, MN (7 miles from Brooklyn Center, MN)
- 19 days ago
At 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 PersonLabeling and Regulatory Compliance Specialist
- Dahl Consulting
- Golden Valley, MN (8 miles from Brooklyn Center, MN)
- 21 days ago
- Golden Valley, MN (8 miles from Brooklyn Center, 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 (10 miles from Brooklyn Center, MN)
- 21 days ago
- Eden Prairie, MN (10 miles from Brooklyn Center, MN)
- 21 days ago
We looking for an experienced Senior Regulatory Affairs Specialist-Product Development....
Hybrid- Graco Inc.
- Dayton, MN (10 miles from Brooklyn Center, MN)
- 21 days ago
- Dayton, MN (10 miles from Brooklyn Center, MN)
- 21 days ago
Job 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 (7 miles from Brooklyn Center, MN)
- 30+ days ago
- Minneapolis, MN (7 miles from Brooklyn Center, 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
- Medtronic
- Minneapolis, MN (7 miles from Brooklyn Center, MN)
- 30+ days ago
- Minneapolis, MN (7 miles from Brooklyn Center, 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 PersonLegal Operations and Compliance Analyst
- HealthEZ
- Minneapolis, MN (7 miles from Brooklyn Center, MN)
- 45+ days ago
- Minneapolis, MN (7 miles from Brooklyn Center, MN)
- 45+ days ago
The Opportunity HealthEZ is seeking a Legal Operations & Compliance Analyst to support its legal, regulatory, and compliance services for its internal and external stakeholders. The Legal...
In PersonCompliance Analyst, Customer Complaints
- Osaic
- Oakdale, MN (21 miles from Brooklyn Center, MN)
- 45+ days ago
- Oakdale, MN (21 miles from Brooklyn Center, MN)
- 45+ days ago
Compliance Opportunity in Financial Services Compliance Analyst, Customer Complaints Location(s): Scottsdale: 18700 N Hayden Rd, Suite 255, Scottsdale, AZ 85255 Atlanta: 2300 Windy Ridge Pkwy SE,...
HybridPrincipal Regulatory Affairs Specialist
- Heidelberg Materials US, Inc.
- Plymouth, MN (4 miles from Brooklyn Center, MN)
- 45+ days ago
- Plymouth, MN (4 miles from Brooklyn Center, MN)
- 45+ days ago
Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained....
In PersonSenior Regulatory Affairs Specialist
- Philips
- Plymouth, MN (4 miles from Brooklyn Center, MN)
- 45+ days ago
- Plymouth, MN (4 miles from Brooklyn Center, MN)
- 45+ days ago
Job Title Senior Regulatory Affairs Specialist Job Description Senior Regulatory Affairs Specialist, Ultrasound The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams...
In PersonDemographic Data for Brooklyn Center, MN
Moving to Brooklyn Center, MN? Find some basic demographic data about Brooklyn Center, MN below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Brooklyn Center, MN
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Brooklyn Center, 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
- 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
- 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
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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