Director of Regulatory Affairs Jobs in Pacheco, 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 APAC - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 9 days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 9 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 Regulatory Affairs Manager APAC - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 30+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 30+ 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 Manager, Regulatory Affairs
- San Francisco, CA (19 miles from Pacheco, CA)
- 9 hours ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 9 hours ago
About the Role Chime is seeking a Senior Manager of Regulatory Affairs to join our Legal and Compliance function. In this role, you will provide strategic leadership and sound judgment to foster...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 1 day ago
- Alameda, CA (15 miles from Pacheco, 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...
Manager, Regulatory Affairs-Document Coordinator
- San Francisco, CA (19 miles from Pacheco, CA)
- 7 days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 7 days ago
regulations (ex-US is a plus) and industry standards pertaining to regulatory Knowledge of the drug development process and eCTD Excellent organization skills and ability to work on multiple projects...
Regulatory Affairs Manager - Canada & Latin America - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 8 days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 8 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...
Commercial Regulatory Affairs Director (Advertising and Promotion)
- Alameda, CA (15 miles from Pacheco, CA)
- 8 days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 8 days ago
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval...
Director, Regulatory Affairs - Labeling
- San Francisco, CA (19 miles from Pacheco, CA)
- 9 days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 9 days ago
About the Role >>> Director, Regulatory Labeling As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of...
Director, Regulatory Affairs and Quality Assurance
- San Francisco, CA (19 miles from Pacheco, CA)
- 14 days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 14 days ago
Ensure an effective Quality Management System (QMS). This is a remote US role....
Remote Work- San Francisco, CA (19 miles from Pacheco, CA)
- 15 days ago
- San Francisco, CA (19 miles from Pacheco, CA)
- 15 days ago
THE COMPANY 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal...
Associate Director Regulatory Affairs - APAC - Diabetes Care
- Alameda, CA (15 miles from Pacheco, CA)
- 30+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 30+ days ago
The Opportunity This Associate Director Regulatory Affairs - APAC will work on-site at our Alameda, CA, location in the Diabetes Division....
Knowledge of compliance with harmonized international standards and regulations relevant to IVD devices such as ISO 13485:2016, ISO 14971:2019, MDSAP Demonstrates strong analytical, critical thinking...
Regulatory Affairs Manager Canada & Latin America Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 45+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 45+ 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...
Commercial Regulatory Affairs Director
- Alameda, CA (15 miles from Pacheco, CA)
- 60+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 60+ days ago
ESSENTIAL DUTIES AND RESPONSIBILITIES: Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval...
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)
- Alameda, CA (15 miles from Pacheco, CA)
- 90+ days ago
- Alameda, CA (15 miles from Pacheco, CA)
- 90+ 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...
Demographic Data for Pacheco, CA
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Director of Regulatory Affairss in Pacheco, 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
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Microbiology
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Verbal Communication
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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