Manager of Regulatory Affairs Jobs in Plymouth, 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.
Regulatory Affairs Manager - Electrophysiology (on-site)
- Plymouth, MN
- 1 day ago
- Plymouth, MN
- 1 day 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...
Associate Director, Regulatory Affairs
- Minneapolis, MN (7 miles from Plymouth, MN)
- 10 days ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 10 days ago
Keywords: Regulatory Affairs, Biologics, Pharmaceuticals, IND Submission, eCTD Format, ESG Portal, FDA Regulations, Clinical Development, Organ Transplant, Bioengineered Organs, Tissue Engineering,...
Assistant Director Regulatory Affairs
- Eden Prairie, MN (6 miles from Plymouth, MN)
- 17 days ago
- Eden Prairie, MN (6 miles from Plymouth, MN)
- 17 days ago
regulation, regulations, food drug administration, lung, lungs, kidneys, hearts, livers,...
Associate Director, Regulatory Affairs
- Minneapolis, MN (7 miles from Plymouth, MN)
- 17 days ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 17 days ago
Stay current with evolving FDA regulations and guidance relevant to biologics and regenerative medicine....
Remote Work- Minneapolis, MN (7 miles from Plymouth, MN)
- 22 days ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 22 days ago
Regulatory 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...
- Minneapolis, MN (7 miles from Plymouth, MN)
- 22 days ago
- Minneapolis, MN (7 miles from Plymouth, MN)
- 22 days ago
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 (8 miles from Plymouth, MN)
- 30+ days ago
- Maple Grove, MN (8 miles from Plymouth, 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 (17 miles from Plymouth, MN)
- 30+ days ago
- Saint Paul, MN (17 miles from Plymouth, 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...
Demographic Data for Plymouth, MN
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Salary for Manager of Regulatory Affairs Jobs in Plymouth, MN
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Plymouth, 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
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Scientific Writing
- Drug Development
- Clinical Trials
- 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
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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