Manager of Regulatory Affairs Jobs in California
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.
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages...
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...
Significant management experience with a proven track record of leading, mentoring, and scaling teams for a minimum of 8-10 years Deep understanding of FDA regulations, FSMA (21 CFR Part 117), DSHEA...
Manager, Regulatory Affairs (International Regulations) - Biosense Webster, Inc.
- Irvine, CA
- 4 days ago
- Irvine, CA
- 4 days ago
Job title Manager, Regulatory Affairs (International Regulations) - Biosense Webster, Inc....
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international...
Position Summary: Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment. In this position, the...
Associate Director, Regulatory Affairs CMC - San Diego, CA
- San Diego, CA
- 7 days ago
- San Diego, CA
- 7 days ago
Mirador is a next-generation precision medicine company focused on immunology and inflammation. The companys Mirador360 TM precision development engine leverages the latest advances in human...
Description Central Garden & Pet is a market leader in the Garden and Pet industries. For over 40 years, Central has proudly nurtured happy and healthy homes by bringing innovative and trusted...
Lead internal/supplier audits and CAPAs; train auditors. Manage document control, sealed source/device registries, and complaint programs....
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic...
Director, Regulatory Affairs - Job ID: DRA Ascendis Pharma - 4.8 Palo Alto, CA Job Details Full-time $225,000 - $240,000 a year 15 hours ago Benefits Paid parental leave Health savings account...
Summary The Senior Manager, Regulatory Affairs is responsible for leading and mentoring Biocare Medical's Regulatory Affairs team, with direct oversight of global regulatory strategy, submissions, and...
Associate Director Regulatory Affairs CMC Acadia Pharmaceuticals Inc. $160,000-$199,600 United States, California, San Diego 12830 El Camino Real (Show on map) Jun 03, 2025 About Acadia...
About Wing: Wing offers drone delivery as a safe, fast, and sustainable solution for last mile logistics. Consumer appetites for on-demand services are increasing, but current delivery methods are...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA
- 13 days ago
- Alameda, CA
- 13 days ago
Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms...
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Salary for Manager of Regulatory Affairs Jobs in California
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in California 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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