Director of Regulatory Affairs Jobs in Minneapolis, 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.
- Minnetonka, MN (8 miles from Minneapolis, MN)
- 3 days ago
- Minnetonka, MN (8 miles from Minneapolis, MN)
- 3 days ago
Director, Regulatory Affairs- This position can be based either in our San Diego, CA or Minnetonka, MN location. Welcome to an inspired career....
Associate Director, Regulatory Affairs
- Eden Prairie, MN (8 miles from Minneapolis, MN)
- 12 days ago
- Eden Prairie, MN (8 miles from Minneapolis, MN)
- 12 days ago
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 (4 miles from Minneapolis, MN)
- 16 days ago
- St Louis Park, MN (4 miles from Minneapolis, 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 (9 miles from Minneapolis, MN)
- 26 days ago
- Saint Paul, MN (9 miles from Minneapolis, MN)
- 26 days ago
The Opportunity This Associate Director Regulatory Affairs will work on-site at our St. Paul, MN location in the Vascular Division....
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 difference in the lives of...
Associate Director, Regulatory Affairs-Front Line Care
- Saint Paul, MN (9 miles from Minneapolis, MN)
- 60+ days ago
- Saint Paul, MN (9 miles from Minneapolis, 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...
Demographic Data for Minneapolis, MN
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Salary for Director of Regulatory Affairs Jobs in Minneapolis, MN
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Director of Regulatory Affairss in Minneapolis, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- 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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