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.
Associate Director, Regulatory Affairs - Cardiac Rhythm Management
- Arden Hills, MN
- 1 day ago
- Arden Hills, MN
- 1 day ago
system activities and regulatory intelligence efforts Process Improvement & Collaboration Contribute to the development of best practices across the Regulatory Affairs function Support due diligence...
regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) location with the option for a remote candidate with monthly travel...
Aufgaben: Regulatory Affairs Manager (m/w/d) Vollzeit Job-Nummer: req218 Bei ulrich medical begeistern wir uns fur die Gesundheit und die Lebensqualitat von Menschen. Teilen Sie unsere...
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 16 days ago
- Plymouth, MN
- 16 days ago
Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive...
Piper Companies is currently looking for an experienced Associate Director of Regulatory Affairs in Eden Prairie, Minnesota (MN) to work for an innovative and growing pharmaceutical manufacturer....
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 18 days ago
- Plymouth, MN
- 18 days ago
As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to...
regulation, regulations, food drug administration, lung, lungs, kidneys, hearts, livers,...
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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
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Biotechnology
- Next-Generation Sequencing
- Medical Affairs
- Masters In Education
- Gene Therapy
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- GxP
- ISO 13485
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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