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)
- Abbott Laboratories
- Santa Clara, CA
- 21 hours ago
- Santa Clara, CA
- 21 hours ago
PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions Experience with Class II and Class III medical devices Ability to define regulatory strategy....
In Person- Hoffmann-La Roche Ltd
- Santa Clara, CA
- 6 days ago
- Santa Clara, CA
- 6 days ago
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued,...
In PersonManager, Regulatory Affairs CMC
- 1010 Gilead Sciences, Inc.
- Foster City, CA (22 miles from Santa Clara, CA)
- 6 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 6 days ago
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop...
In PersonAssociate Director, Regulatory Affairs Advertising and Promotion
- Mirum Pharmaceuticals Inc
- Foster City, CA (22 miles from Santa Clara, CA)
- 7 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 7 days ago
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...
HybridManager, Regulatory Affairs CMC
- Gilead Sciences
- Foster City, CA (22 miles from Santa Clara, CA)
- 8 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 8 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...
In PersonDirector, Regulatory Affairs (Clinical)
- Bayside Solutions
- Redwood City, CA (17 miles from Santa Clara, CA)
- 10 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 10 days ago
Director, Regulatory Affairs (Clinical) in Redwood City, California Overview Director, Regulatory Affairs (Clinical) W2 Contract Pay Rate: $100 - $125 per hour Location: Redwood City, CA - Remote...
Remote- Revolution Medicines
- Redwood City, CA (17 miles from Santa Clara, CA)
- 27 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 27 days ago
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R D pipeline comprises RAS(ON) inhibitors...
RemoteSenior Manager, Regulatory Affairs
- Hyperfine Inc
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 45+ days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 45+ days ago
Learn More About The Role Job Title: Senior Manager, Regulatory Affairs Location: Guilford, CT or Palo Alto, CA (Hybrid, 3 days/week) The Senior Manager, Regulatory Affairs owns and executes U.S. and...
HybridDirector Regulatory Affairs - Cardiac
- Intuitive
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 45+ days ago
- Sunnyvale, CA (4 miles from Santa Clara, CA)
- 45+ days ago
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive....
In PersonAssociate Director, Regulatory Affairs CMC
- Gilead Sciences
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 60+ 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...
In PersonSenior Manager, Regulatory Affairs
- Revolution Medicines, Inc.
- Redwood City, CA (17 miles from Santa Clara, CA)
- 60+ days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 60+ 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...
HybridDirector, Regulatory Affairs CMC
- Corcept Therapeutics
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 90+ days ago
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial...
HybridDemographic Data for Santa Clara, CA
Moving to Santa Clara, CA? Find some basic demographic data about Santa Clara, CA below.
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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
- 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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