Director of Regulatory Affairs Jobs in Santa Clara, CA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Regulatory Affairs Manager Heart Failure (on-site)
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 45+ days ago
- Pleasanton, CA (21 miles from Santa Clara, CA)
- 45+ days 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...
Associate Director, Regulatory Affairs
- Redwood City, CA (17 miles from Santa Clara, CA)
- 5 days ago
- Redwood City, CA (17 miles from Santa Clara, CA)
- 5 days ago
The Opportunity: The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology....
Director, Regulatory Affairs - Job ID: DRA
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 7 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 7 days ago
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 AD&D...
Airworthiness and Regulatory Affairs Manager
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 9 days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 9 days ago
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...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (22 miles from Santa Clara, CA)
- 21 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 21 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...
Associate Director, Regulatory Affairs - Global Labeling
- Foster City, CA (22 miles from Santa Clara, CA)
- 23 days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 23 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...
Sr Regulatory Affairs Manager, Abbott Ventures - Transcatheter Mitral Valve Replacement (on-site)
- Santa Clara, CA
- 29 days ago
- Santa Clara, CA
- 29 days ago
Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities....
Sr Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair (on-site)
- Santa Clara, CA
- 45+ days ago
- Santa Clara, CA
- 45+ days ago
Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities....
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA
- 45+ days ago
- Santa Clara, CA
- 45+ days 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, Regulatory Affairs - Job ID: SDRA
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 45+ days ago
- Palo Alto, CA (12 miles from Santa Clara, CA)
- 45+ days ago
Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team....
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 60+ days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 60+ 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 studies...
Executive Director, Regulatory Affairs
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 60+ days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 60+ 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...
Director, Regulatory Affairs Global Labeling
- 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...
Senior Manager, Regulatory Affairs
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 90+ days ago
- Menlo Park, CA (14 miles from Santa Clara, CA)
- 90+ 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. These assigned projects...
Associate Director, Regulatory Affairs
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ days ago
- Foster City, CA (22 miles from Santa Clara, CA)
- 90+ days ago
POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization...
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Director 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 Director of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Complaint Resolution
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- 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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