Regulatory Affairs Specialist Jobs in Union City, 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 Payroll Tax & Compliance Analyst
- San Francisco, CA (23 miles from Union City, CA)
- 1 day ago
- San Francisco, CA (23 miles from Union City, CA)
- 1 day ago
Morrison & Foerster LLP ID: 9878 Job Posting Title: Senior Payroll Tax & Compliance Analyst Location: Office Location Flexible At MoFo, we couldn't write our own success story without yours. Ready...
Regulatory Affairs Specialist II - Heart Failure
- Pleasanton, CA (11 miles from Union City, CA)
- 2 days ago
- Pleasanton, CA (11 miles from Union City, CA)
- 2 days ago
This Regulatory Affairs Specialist II will work out of our Pleasanton, CA location in our Heart Failure Division....
- San Francisco, CA (23 miles from Union City, CA)
- 3 days ago
- San Francisco, CA (23 miles from Union City, CA)
- 3 days ago
Conduct regular risk assessments and internal audits to identify compliance gaps and recommend remediation measures....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (11 miles from Union City, CA)
- 4 days ago
- Pleasanton, CA (11 miles from Union City, CA)
- 4 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...
Regulatory Affairs Specialist II
- Alameda, CA (17 miles from Union City, CA)
- 5 days ago
- Alameda, CA (17 miles from Union City, CA)
- 5 days ago
., Instructions for Use and product labels) Understand the Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements....
- Santa Clara, CA (18 miles from Union City, CA)
- 5 days ago
- Santa Clara, CA (18 miles from Union City, CA)
- 5 days ago
Job Title: Associate Regulatory Affairs Specialist, Operations Looking for an entry level candidate looking to gain experience in Regulatory Affairs, NO EXPERIENCE NEEDED....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (11 miles from Union City, CA)
- 5 days ago
- Pleasanton, CA (11 miles from Union City, CA)
- 5 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...
Sr Regulatory Operations Specialist (Remote) - Shockwave
- Santa Clara, CA (18 miles from Union City, CA)
- 5 days ago
- Santa Clara, CA (18 miles from Union City, CA)
- 5 days ago
The function of the Senior Regulatory Affairs Specialist, Operations, includes providing submission publishing/verification support and Regulatory compliance support....
Remote WorkSr Regulatory Affairs Specialist (Remote) - Shockwave
- Santa Clara, CA (18 miles from Union City, CA)
- 5 days ago
- Santa Clara, CA (18 miles from Union City, CA)
- 5 days ago
J&J Family of Companies Sr Regulatory Affairs Specialist (Remote) - Shockwave in Santa Clara , California At Johnson & Johnson,we believe health is everything....
Remote WorkData Security Compliance Analyst
- San Francisco, CA (23 miles from Union City, CA)
- 5 days ago
- San Francisco, CA (23 miles from Union City, CA)
- 5 days ago
Data Security Compliance Analyst involves monitoring, detecting, protecting and maintaining the security of data, systems and networks. Plans, configures, designs, develops, implements and...
- Oakland, CA (15 miles from Union City, CA)
- 6 days ago
- Oakland, CA (15 miles from Union City, CA)
- 6 days ago
Candidates must be local to work location/Bay Area and will be required in office 1-2 times per month at Oakland General Office. PG&E laptop, monitor, docking station, mouse, and keyboard will be...
Trade Compliance Analyst - INTL - India
- Milpitas, CA (17 miles from Union City, CA)
- 8 days ago
- Milpitas, CA (17 miles from Union City, CA)
- 8 days ago
Insight Global Trade Compliance Analyst - INTL - India in Milpitas , California Job Description Trade compliance analyst who will play a key role in ensuring our organization's adherence to trade...
Regulatory Operations Specialist
- San Francisco, CA (23 miles from Union City, CA)
- 9 days ago
- San Francisco, CA (23 miles from Union City, CA)
- 9 days ago
Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional....
Contract Compliance, Analyst - CA - (REMOTE)
- Berkeley, CA (22 miles from Union City, CA)
- 11 days ago
- Berkeley, CA (22 miles from Union City, CA)
- 11 days ago
We are one of the first work-from-anywhere companies with 2,000+ team members utilizing our virtual office called eXp World. This role is work-from-anywhere in California. Who is eXp? Doing the...
Remote WorkClinical Senior Compliance Analyst
- San Francisco, CA (23 miles from Union City, CA)
- 11 days ago
- San Francisco, CA (23 miles from Union City, CA)
- 11 days ago
Clinical Senior Compliance Analyst University of California, United States about 7 hours ago Location: San Francisco, CALIFORNIA Deadline: ; Clinical Enterprise Comp Full Time 80595BR Job Summary...
Remote WorkDemographic Data for Union City, CA
Moving to Union City, CA? Find some basic demographic data about Union City, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Union City, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Union City, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Institutional Review Board
- Internal Audits
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Lean Six Sigma
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- 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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