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 Regulatory Affairs Specialist Vascular (on-site)
- Santa Clara, CA (18 miles from Union City, CA)
- 60+ days ago
- Santa Clara, CA (18 miles from Union City, CA)
- 60+ days ago
This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division....
Compliance Analyst - Cyber Security
- Menlo Park, CA (12 miles from Union City, CA)
- 6 hours ago
- Menlo Park, CA (12 miles from Union City, CA)
- 6 hours ago
Skills: Heavy focus on cybersecurity standards compliance, specifically HITRUST, SOC 2, and ISO frameworks. Work involves significant use of the GRC tool (Vanta) (about 80% of efforts)....
- Menlo Park, CA (12 miles from Union City, CA)
- 6 hours ago
- Menlo Park, CA (12 miles from Union City, CA)
- 6 hours ago
Compliance Analyst Location: Menlo Park, CA (2-3 days onsite, then the rest remote) Duration: 5+ Months Contract (Could extend) Looking for candidates with this experience and skills: A strong...
- San Francisco, CA (23 miles from Union City, CA)
- 12 hours ago
- San Francisco, CA (23 miles from Union City, CA)
- 12 hours ago
Join to apply for the Senior Compliance Analyst role at Qcells North America 3 days ago Be among the first 25 applicants Join to apply for the Senior Compliance Analyst role at Qcells North...
Senior Regulatory Affairs Specialist
- Redwood City, CA (14 miles from Union City, CA)
- 15 hours ago
- Redwood City, CA (14 miles from Union City, CA)
- 15 hours ago
Pulmonx is looking for a Sr Regulatory Affairs Specialist to join our team supporting all regulatory aspects of our groundbreaking medical devices....
Export Compliance Analyst / Customer Service
- San Jose, CA (19 miles from Union City, CA)
- 2 days ago
- San Jose, CA (19 miles from Union City, CA)
- 2 days ago
Management System and Environmental Management System....
Senior Global Trade Compliance Analyst (P-4672)
- Pleasanton, CA (11 miles from Union City, CA)
- 2 days ago
- Pleasanton, CA (11 miles from Union City, CA)
- 2 days ago
[Insert Job Description] About 10x Genomics At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the...
- Palo Alto, CA (12 miles from Union City, CA)
- 3 days ago
- Palo Alto, CA (12 miles from Union City, CA)
- 3 days ago
Position Overview: We are seeking an experienced SOX Compliance & GRC Analyst to lead our SOX IT General Controls program while supporting our broader governance, risk, and compliance initiatives....
Associate Export & Compliance Analyst
- Campbell, CA (22 miles from Union City, CA)
- 4 days ago
- Campbell, CA (22 miles from Union City, CA)
- 4 days ago
Associate Export & Compliance Analyst Dallas Metro AreaLegal Division - Legal /Full Time Employee /On-Site Founded in 2015, Shield AI is a venture-backed defense technology company with the...
Sr Regulatory Affairs Specialist - Shockwave Medical
- Santa Clara, CA (18 miles from Union City, CA)
- 4 days ago
- Santa Clara, CA (18 miles from Union City, CA)
- 4 days ago
Job title Sr Regulatory Affairs Specialist - Shockwave Medical Function Regulatory Affairs Group Sub function Regulatory Affairs Category Experienced Analyst, Regulatory Affairs (P5) Location Santa...
Remote WorkRegulatory Affairs Specialist, NPD
- Sunnyvale, CA (14 miles from Union City, CA)
- 5 days ago
- Sunnyvale, CA (14 miles from Union City, CA)
- 5 days ago
Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain...
- Livermore, CA (23 miles from Union City, CA)
- 6 days ago
- Livermore, CA (23 miles from Union City, CA)
- 6 days ago
Trade Compliance Analyst FormFactor, Inc Hybrid- Livermore, CA May also consider Beaverton, OR In a world driven by the increased demand of technology, semiconductor manufacturers require a...
- Oakland, CA (15 miles from Union City, CA)
- 9 days ago
- Oakland, CA (15 miles from Union City, CA)
- 9 days ago
Compliance Analyst Oakland, CA Approximate contract length is 5+ Months ONLY SUBMIT CANDIDATES CURRENTLY RESIDING IN BAY AREA/NEAR WORK LOCATION-OAKLAND. ASSIGMENT IS HYBRID AND REQUIRED...
Compliance Analyst/ Senior Compliance Consultant
- Oakland, CA (15 miles from Union City, CA)
- 9 days ago
- Oakland, CA (15 miles from Union City, CA)
- 9 days ago
**********LOCAL CANDIDATES ONLY***NO C2C*************** Title Compliance Analyst Location - Oakland, CA (hybrid) Pay Range: 60k -77k/annum Job id - 3312 Description: LOOKING FOR CANDIDATES...
Supply Chain Compliance Analyst
- San Jose, CA (19 miles from Union City, CA)
- 12 days ago
- San Jose, CA (19 miles from Union City, CA)
- 12 days ago
Certifications like CISA, CISM, or ISO Lead Auditor are a plus. 3+ years of experience in compliance, supply chain operations, process improvement, or internal audit-ideally within hardware-intensive...
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
- Vendor Management
- Reimbursement
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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