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.
Keywords: Regulatory Affairs, Biologics, Pharmaceuticals, IND Submission, eCTD Format, ESG Portal, FDA Regulations, Clinical Development, Organ Transplant, Bioengineered Organs, Tissue Engineering,...
regulation, regulations, food drug administration, lung, lungs, kidneys, hearts, livers,...
Stay current with evolving FDA regulations and guidance relevant to biologics and regenerative medicine....
Remote WorkRegulatory Affairs Manager Apply now **Date:** Jul 9, 2025 **Location:** Minneapolis, MN, US, 55402 **Company:** CenterPoint Energy **CenterPoint Energy and its predecessor companies have been in...
You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21 CFR 820, etc.)...
Director of Regulatory Affairs - Medical Devices
- Maple Grove, MN
- 30+ days ago
- Maple Grove, MN
- 30+ days ago
Strong knowledge of global regulatory standards and quality systems, including ISO 13485, GMP, GCP, GLP, QSR, and MDR....
Associate Director, Regulatory Affairs - Cardiac Rhythm Management
- Saint Paul, MN
- 30+ days ago
- Saint Paul, MN
- 30+ days 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...
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 45+ days ago
- Plymouth, MN
- 45+ 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...
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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
- Biochemistry
- Biology
- Immunology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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