Regulatory Affairs Specialist Jobs in Antioch, 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 Specialist I - Heart Failure (on-site)
- Pleasanton, CA (23 miles from Antioch, CA)
- 3 days ago
- Pleasanton, CA (23 miles from Antioch, CA)
- 3 days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
Regulatory Affairs Specialist II - Heart Failure
- Pleasanton, CA (23 miles from Antioch, CA)
- 12 hours ago
- Pleasanton, CA (23 miles from Antioch, CA)
- 12 hours ago
This Regulatory Affairs Specialist II will work out of our Pleasanton, CA location in our Heart Failure Division....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (23 miles from Antioch, CA)
- 2 days ago
- Pleasanton, CA (23 miles from Antioch, CA)
- 2 days ago
Pleasanton : 6101 Stoneridge Dr ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms...
- Pleasanton, CA (23 miles from Antioch, CA)
- 9 days ago
- Pleasanton, CA (23 miles from Antioch, CA)
- 9 days ago
About the company Albertsons Companies is at the forefront of the revolution in retail. With a fixation on raising the bar with innovation and building belonging through our culture, our team is...
Principal Regulatory Affairs Specialist - Heart Failure (on-site)
- Pleasanton, CA (23 miles from Antioch, CA)
- 15 days ago
- Pleasanton, CA (23 miles from Antioch, CA)
- 15 days ago
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)....
Demographic Data for Antioch, CA
Moving to Antioch, CA? Find some basic demographic data about Antioch, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Antioch, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Antioch, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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