Manager of Regulatory Affairs Jobs in Minnesota
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Cullinan Therapeutics, Inc.(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. We have strategically built a diversified portfolio of...
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regulations, including 21 CFR 1271 and 21 CFR 312 Job Location This role is located onsite in our Eden Prairie, MN (Miromatrix) location....
Regulatory Affairs Manager (St Louis Park, MN)
- St Louis Park, MN
- 16 days ago
- St Louis Park, MN
- 16 days ago
Client is seeking a Regulatory Affairs Manager who will be an integral part of the Global Regulatory Policy & Registration Team. Reporting to the Director, Regulatory Science and Operations, this...
Associate Director Regulatory Affairs - Vascular (on-site)
- Saint Paul, MN
- 26 days ago
- Saint Paul, MN
- 26 days ago
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements....
RETROPHIN INC. Executive Director, Regulatory Affairs in Minneapolis , Minnesota Department: 107000 Regulatory Location: USA- Remote Be a part of a global team that is inspired to make a...
Associate Director, Regulatory Affairs-Front Line Care
- Saint Paul, MN
- 60+ days ago
- Saint Paul, MN
- 60+ days ago
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel...
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Salary for Manager of Regulatory Affairs Jobs in Minnesota
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Minnesota offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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