Director of Regulatory Affairs Jobs in Sunnyvale, 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.
Senior Director, Regulatory Affairs Strategy and Compliance
- San Mateo, CA (20 miles from Sunnyvale, CA)
- 13 hours ago
- San Mateo, CA (20 miles from Sunnyvale, CA)
- 13 hours ago
General Description:** The Senior Director, Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive regulatory strategies to ensure compliance with global...
- San Jose, CA (7 miles from Sunnyvale, CA)
- 7 days ago
- San Jose, CA (7 miles from Sunnyvale, CA)
- 7 days ago
The Regulatory Affairs Manager will be responsible for developing and executing regulatory strategies for medical devices in accordance with health authority regulations/guidance and global...
Sr Regulatory Affairs Manager - Transcatheter Mitral and Tricuspid Valve Repair (on-site)
- Santa Clara, CA (4 miles from Sunnyvale, CA)
- 11 days ago
- Santa Clara, CA (4 miles from Sunnyvale, CA)
- 11 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 (4 miles from Sunnyvale, CA)
- 12 days ago
- Santa Clara, CA (4 miles from Sunnyvale, CA)
- 12 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...
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Regulatory Affairs Manager - Heart Failure (on-site)
- Pleasanton, CA (19 miles from Sunnyvale, CA)
- 13 days ago
- Pleasanton, CA (19 miles from Sunnyvale, CA)
- 13 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 (8 miles from Sunnyvale, CA)
- 15 days ago
- Palo Alto, CA (8 miles from Sunnyvale, CA)
- 15 days ago
Director, Regulatory Affairs will serve as the therapeutic area head for assigned products and lead the US RA Strategy team....
- Palo Alto, CA (8 miles from Sunnyvale, CA)
- 17 days ago
- Palo Alto, CA (8 miles from Sunnyvale, CA)
- 17 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 responsible...
Sr Manager, Regulatory Affairs
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 30+ days ago
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 30+ 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...
Senior Manager, Regulatory Affairs
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 30+ days ago
- Redwood City, CA (13 miles from Sunnyvale, CA)
- 30+ 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...
Director, Regulatory Affairs Labeling Execution
- Foster City, CA (17 miles from Sunnyvale, CA)
- 30+ days ago
- Foster City, CA (17 miles from Sunnyvale, CA)
- 30+ days ago
In-depth knowledge in labeling operations compliance, including quality management processes and systems....
Senior Director, Regulatory Affairs Global Regulatory Leader
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 30+ days ago
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 30+ 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 (10 miles from Sunnyvale, CA)
- 30+ days ago
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 30+ 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...
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Director, Regulatory Affairs Global Labeling
- Foster City, CA (17 miles from Sunnyvale, CA)
- 45+ days ago
- Foster City, CA (17 miles from Sunnyvale, CA)
- 45+ 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 (10 miles from Sunnyvale, CA)
- 60+ days ago
- Menlo Park, CA (10 miles from Sunnyvale, CA)
- 60+ 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...
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Director of Regulatory Affairss in Sunnyvale, 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
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Management Systems
- Quality Systems
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Auditing
- 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
- Leadership
- Communication Skills
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