Manager of Regulatory Affairs Jobs in Seal Beach, CA
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
- Dendreon Pharmaceuticals LLC
- Seal Beach, CA
- 9 hours ago
- Seal Beach, CA
- 9 hours ago
Overview Who We Are: At Dendreon, were transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved...
In PersonDirector of Regulatory Affairs
- Radiant Nuclear
- El Segundo, CA (21 miles from Seal Beach, CA)
- 21 hours ago
- El Segundo, CA (21 miles from Seal Beach, CA)
- 21 hours ago
About Radiant Radiant is an El Segundo, CA-based startup building the world's first mass-produced, portable nuclear microreactors. The company's first reactor, Kaleidos, is a 1-megawatt, fail-safe...
In Person- ABODE COMMUNITIES
- Los Angeles, CA (17 miles from Seal Beach, CA)
- 4 days ago
- Los Angeles, CA (17 miles from Seal Beach, CA)
- 4 days ago
Regulatory Affairs Manager ABODE COMMUNITIES - 3.2 Los Angeles, CA Job Details Full-time $90,000 - $103,000 a year 16 hours ago Qualifications Stakeholder relationship building Full Job...
In PersonDirector, Regulatory Affairs Devices and Combination Products
- AbbVie, Inc
- Irvine, CA (19 miles from Seal Beach, CA)
- 5 days ago
- Irvine, CA (19 miles from Seal Beach, CA)
- 5 days ago
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of...
In PersonRegulatory Affairs & Quality Assurance Manager
- University of California System
- Orange, CA (13 miles from Seal Beach, CA)
- 13 days ago
- Orange, CA (13 miles from Seal Beach, CA)
- 13 days ago
Responsibilities Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Manager of Regulatory Affairs and Quality Assurance...
In PersonDirector, Regulatory Affairs Strategy
- Alcon
- Lake Forest, CA (24 miles from Seal Beach, CA)
- 17 days ago
- Lake Forest, CA (24 miles from Seal Beach, CA)
- 17 days ago
At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global...
In PersonManager, Regulatory Affairs THV
- Edwards Lifesciences
- Irvine, CA (19 miles from Seal Beach, CA)
- 30+ days ago
- Irvine, CA (19 miles from Seal Beach, CA)
- 30+ days ago
(e.g., ITA's, IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files) Provide guidance on regulatory requirements necessary for strategic and contingency planning...
In PersonProject Manager, Regulatory Affairs (VALVE)
- JENAVALVE TECHNOLOGY INC
- Irvine, CA (19 miles from Seal Beach, CA)
- 45+ days ago
- Irvine, CA (19 miles from Seal Beach, CA)
- 45+ days ago
Title : Project Manager, Regulatory Affairs Role Level: Individual Contributor Supervisor/Manager Title: Senior Manager, Regulatory Affairs Job Location & Environment: Irvine, CA - Corporate Office...
In PersonAssociate Director, Regulatory Affairs Advertising & Promotion (Office-based)
- AbbVie, Inc
- Irvine, CA (19 miles from Seal Beach, CA)
- 60+ days ago
- Irvine, CA (19 miles from Seal Beach, CA)
- 60+ days ago
Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of...
Hybrid- iRhythm Technologies
- Orange, CA (13 miles from Seal Beach, CA)
- 90+ days ago
- Orange, CA (13 miles from Seal Beach, CA)
- 90+ days ago
System Monitoring the impact of changing global regulations on submission strategies & registrations Support external and internal audits Perform other regulatory-related duties as assigned....
In PersonDemographic Data for Seal Beach, CA
Moving to Seal Beach, CA? Find some basic demographic data about Seal Beach, CA below.
Manager of Regulatory Affairs Online Courses and Training Opportunities
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Salary for Manager of Regulatory Affairs Jobs in Seal Beach, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Seal Beach, CA 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
- Virology
- Immunology
- Oncology
- Medical Writing
- Drug Development
- Neuroscience
- Biostatistics
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Good Laboratory Practice
- ISO 13485
- Microbiology
- Document Management
- Research and Development
- Medical Device Sales
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Analytical Skills
- Quality Assurance
- Engineering
- Strategy Development
- Auditing
- Process Improvement
- Documentation
- Coaching
- Mentoring
- Interpersonal Skills
- Writing Skills
- Implementation
- Verbal Communication
- Reporting
- Education Experience
- Collaboration
- Bachelor's Degree
- Regulations
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Teamwork
- Leadership
- Communication Skills
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