Regulatory Affairs Specialist Jobs in Dublin, 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 Coordinator
- Walnut Creek, CA (13 miles from Dublin, CA)
- 2 days ago
- Walnut Creek, CA (13 miles from Dublin, CA)
- 2 days ago
We are seeking a proactive and strategic Regulatory Affairs Coordinator to join our team and support both our Workers’ Compensation and Healthcare lines of business. In this highly visible role,...
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (5 miles from Dublin, CA)
- 4 days ago
- Pleasanton, CA (5 miles from Dublin, CA)
- 4 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...
Senior Regulatory Affairs Specialist IVD
- Sunnyvale, CA (23 miles from Dublin, CA)
- 6 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 6 days ago
Senior Regulatory Affairs Specialist, Global Market Protection Location : Remote Shift : M-F, standard working hours Pay : $47/hr-$50/hr 6 month contract role Overview: The Regulatory Affairs Senior...
Compliance Analyst (HITRUST framework)
- Menlo Park, CA (23 miles from Dublin, CA)
- 6 days ago
- Menlo Park, CA (23 miles from Dublin, CA)
- 6 days ago
Conduct risk assessments, gap analyses, and internal audits to identify vulnerabilities and ensure compliance with industry standards....
Product Regulatory Compliance Specialist
- Fremont, CA (11 miles from Dublin, CA)
- 7 days ago
- Fremont, CA (11 miles from Dublin, CA)
- 7 days ago
The Group Youll Be A Part Of In the Global Products Group, we are dedicated to excellence in the design and engineering of Lam's etch and deposition products. We drive innovation to ensure our...
Senior Regulatory Affairs Specialist - IVD
- Sunnyvale, CA (23 miles from Dublin, CA)
- 8 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 8 days ago
Senior Regulatory Affairs Specialist, Global Market Protection Location : Remote Shift : M-F, standard working hours Pay : $47/hr-$50/hr 6 month contract role Overview: The Regulatory Affairs Senior...
- Pleasanton, CA (5 miles from Dublin, CA)
- 12 days ago
- Pleasanton, CA (5 miles from Dublin, CA)
- 12 days ago
Innova Solutions is immediately hiring for an IT SOX Compliance Analyst Position type: Full-time, Contract Duration: 6+ months Location: Pleasanton, CA hybrid As an IT SOX Compliance Analyst you...
- Pleasant Hill, CA (18 miles from Dublin, CA)
- 12 days ago
- Pleasant Hill, CA (18 miles from Dublin, CA)
- 12 days ago
WHO WE ARE Relation Insurance is a leading, innovative company with a strong commitment to excellence and a passion for delivering cutting-edge solutions to our clients. As a key player in the...
- Pleasant Hill, CA (18 miles from Dublin, CA)
- 13 days ago
- Pleasant Hill, CA (18 miles from Dublin, CA)
- 13 days ago
WHO WE ARE Relation Insurance is a leading, innovative company with a strong commitment to excellence and a passion for delivering cutting-edge solutions to our clients. As a key player in the...
Staff Regulatory Affairs Specialist - Hybrid
- Milpitas, CA (20 miles from Dublin, CA)
- 15 days ago
- Milpitas, CA (20 miles from Dublin, CA)
- 15 days ago
Job Overview The Staff Regulatory Affairs Specialist is part of the team responsible for Core Business New Product Development with a focus on compliance to regulations from the US Food Drug & Administration...
Regulatory Affairs Specialist - (NMPA/CFDA)
- Sunnyvale, CA (23 miles from Dublin, CA)
- 22 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 22 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Regulatory Compliance Specialist
- Livermore, CA (20 miles from Dublin, CA)
- 23 days ago
- Livermore, CA (20 miles from Dublin, CA)
- 23 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...
- Pleasanton, CA (5 miles from Dublin, CA)
- 25 days ago
- Pleasanton, CA (5 miles from Dublin, CA)
- 25 days ago
IT SOX Compliance Analyst 1917 A leading enterprise software solutions company is seeking an IT SOX Compliance Analyst. The successful candidate will support audit and Sarbanes-Oxley (SOX)...
Principal Regulatory Affairs Specialist (Business Partnerships).
- Alameda, CA (20 miles from Dublin, CA)
- 28 days ago
- Alameda, CA (20 miles from Dublin, CA)
- 28 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)....
- Walnut Creek, CA (13 miles from Dublin, CA)
- 29 days ago
- Walnut Creek, CA (13 miles from Dublin, CA)
- 29 days ago
Location: Menlo Park, CA; Rancho Cucamonga, CA; or Walnut Creek, CA Work Arrangement: In Office or Hybrid Typical Day in the Life A typical day as a Payroll Compliance Analyst (Associate) might...
Demographic Data for Dublin, CA
Moving to Dublin, CA? Find some basic demographic data about Dublin, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Dublin, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Dublin, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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