Manager of Regulatory Affairs Jobs in Santa Clara, 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.
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA
- 10 hours ago
- Santa Clara, CA
- 10 hours ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Director Regulatory Affairs CMC
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 1 day ago
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 1 day ago
Support product development, manufacturing changes, and quality systems compliance throughout the product lifecycle....
Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 1 day ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 1 day ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
Senior Director / Executive Director of Regulatory Affairs
- Santa Clara, CA
- 2 days ago
- Santa Clara, CA
- 2 days ago
Senior Director / Executive Director of Regulatory Affairs W2 Contract-to-Hire Salary Range: $343,200 - $364,000 per year Location: Redwood City, CA - Hybrid or Remote PST Duties and...
Senior Director, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 3 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 3 days ago
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease...
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 5 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 5 days ago
Position OverviewWe are seeking an experienced Director of Regulatory Affairs to develop and execute global regulatory strategies across clinical, non-clinical, and CMC areas.This role will be...
Sr Manager, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 18 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 18 days ago
Sr Manager, Regulatory Affairs at Corcept Therapeutics Redwood City, California, United States Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate...
Senior Manager, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 19 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 19 days ago
The Opportunity: The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA (22 miles from Santa Clara, CA)
- 20 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 20 days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Associate Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 20 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 20 days ago
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline...
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 26 days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 26 days ago
Overview of Role: The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various...
Executive Director, Regulatory Affairs
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 26 days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 26 days ago
Overview of Role: The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various...
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 30+ days ago
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 30+ days ago
Job Description Primary Function of Position As Senior Manager, Regulatory Affairs, you will lead and manage a team responsible for developing and executing regulatory strategies within the Multiport...
Director, Regulatory Affairs Global Labeling
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 30+ days ago
At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...
Senior Manager, Regulatory Affairs
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 45+ days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 45+ days ago
Overview of Role: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects....
Demographic Data for Santa Clara, CA
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Salary for Manager of Regulatory Affairs Jobs in Santa Clara, CA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Santa Clara, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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