Director of Regulatory Affairs Jobs in San Jose, 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.
- Santa Clara, CA (3 miles from San Jose, CA)
- 1 day ago
- Santa Clara, CA (3 miles from San Jose, CA)
- 1 day ago
We are seeking a highly skilled and proactive Regulatory Affairs Consultant to support our clinical-stage regulatory programs. Preference will be given to candidates based on or comfortable...
Regulatory Affairs Manager - Heart Failure
- Pleasanton, CA (20 miles from San Jose, CA)
- 2 days ago
- Pleasanton, CA (20 miles from San Jose, CA)
- 2 days ago
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to: Career development with...
Associate Director, Regulatory Affairs - Labeling Management
- San Jose, CA
- 6 days ago
- San Jose, CA
- 6 days ago
Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions,...
Associate Director, Regulatory Affairs
- Redwood City, CA (21 miles from San Jose, CA)
- 9 days ago
- Redwood City, CA (21 miles from San Jose, CA)
- 9 days ago
The Opportunity: The Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development...
- Redwood City, CA (21 miles from San Jose, CA)
- 18 days ago
- Redwood City, CA (21 miles from San Jose, CA)
- 18 days ago
The Opportunity: The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed....
Regulatory Affairs Manager Vascular (on-site)
- Santa Clara, CA (3 miles from San Jose, CA)
- 90+ days ago
- Santa Clara, CA (3 miles from San Jose, 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 San Jose, CA
Moving to San Jose, CA? Find some basic demographic data about San Jose, CA below.
Director of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Director of Regulatory Affairs Jobs in San Jose, CA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in San Jose, 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
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Good Manufacturing Practices
- Product Launch
- Document Management
- Medical Device Sales
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Process Improvement
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- 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
Other Career Titles
Here are some other career titles that require similar skills
Director of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »