Manager of Regulatory Affairs Jobs in St Louis Park, MN
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.
Associate Director Regulatory Affairs - Remote
- Minnetonka, MN (4 miles from St Louis Park, MN)
- 12 hours ago
- Minnetonka, MN (4 miles from St Louis Park, MN)
- 12 hours ago
UnitedHealth Group is a health care and well-being company that’s dedicated to improving the health outcomes of millions around the world. We are comprised of two distinct and complementary...
Remote WorkDirector of Regulatory Affairs
- Saint Paul, MN (12 miles from St Louis Park, MN)
- 1 day ago
- Saint Paul, MN (12 miles from St Louis Park, MN)
- 1 day ago
Working knowledge of Medical Device quality systems Understating of ISO 13485, FDA QSR 820, ISO 14971 Preferred Skills & Abilities Strong communication and interpersonal skills, including the ability...
Senior Manager, Regulatory Affairs
- Saint Paul, MN (12 miles from St Louis Park, MN)
- 12 days ago
- Saint Paul, MN (12 miles from St Louis Park, MN)
- 12 days ago
**Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Regulatory Affairs**....
- Minnetonka, MN (4 miles from St Louis Park, MN)
- 20 days ago
- Minnetonka, MN (4 miles from St Louis Park, MN)
- 20 days ago
Save time and apply through your LinkedIn account. Click the Apply with LinkedIn button and your LinkedIn profile will be imported into our site. In order to move forward, you will need to create...
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Associate Director, Regulatory Affairs
- Eden Prairie, MN (4 miles from St Louis Park, MN)
- 29 days ago
- Eden Prairie, MN (4 miles from St Louis Park, MN)
- 29 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....
Associate Director Regulatory Affairs - Vascular (on-site)
- Saint Paul, MN (12 miles from St Louis Park, MN)
- 30+ days ago
- Saint Paul, MN (12 miles from St Louis Park, MN)
- 30+ 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....
Demographic Data for St Louis Park, MN
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Salary for Manager of Regulatory Affairs Jobs in St Louis Park, MN
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in St Louis Park, MN offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Leadership
- Communication Skills
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