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.
- Alameda, CA (20 miles from Dublin, CA)
- 5 days ago
- Alameda, CA (20 miles from Dublin, CA)
- 5 days ago
The Opportunity As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business...
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (5 miles from Dublin, CA)
- 5 days ago
- Pleasanton, CA (5 miles from Dublin, 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...
Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Alameda, CA (20 miles from Dublin, CA)
- 13 days ago
- Alameda, CA (20 miles from Dublin, CA)
- 13 days ago
The Opportunity As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including...
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA (20 miles from Dublin, CA)
- 45+ days ago
- Alameda, CA (20 miles from Dublin, CA)
- 45+ 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)....
- Alameda, CA (20 miles from Dublin, CA)
- 1 day ago
- Alameda, CA (20 miles from Dublin, CA)
- 1 day ago
Alameda : 1360-1380 South Loop Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Regulatory Affairs Specialist 2
- Sunnyvale, CA (23 miles from Dublin, CA)
- 3 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 3 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...
Senior Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (20 miles from Dublin, CA)
- 4 days ago
- Alameda, CA (20 miles from Dublin, CA)
- 4 days ago
Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Senior Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (20 miles from Dublin, CA)
- 5 days ago
- Alameda, CA (20 miles from Dublin, CA)
- 5 days ago
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US on-site at our Alameda, CA location...
Regulatory Affairs Specialist Mandarin Speaking
- Sunnyvale, CA (23 miles from Dublin, CA)
- 6 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 6 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 Operations Specialist
- Newark, CA (15 miles from Dublin, CA)
- 10 days ago
- Newark, CA (15 miles from Dublin, CA)
- 10 days ago
Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional....
Regulatory Affairs Specialist - Pleasanton, CA
- Pleasanton, CA (5 miles from Dublin, CA)
- 10 days ago
- Pleasanton, CA (5 miles from Dublin, CA)
- 10 days ago
devices, including the Quality System Regulation (QSR), Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs)....
Regulatory Affairs Specialist or Senior Regulatory Affairs Specialist
- Sunnyvale, CA (23 miles from Dublin, CA)
- 14 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 14 days ago
Salary Range: Regulatory Affairs Specialist: $90,600 - $116,400* Senior Regulatory Affairs Specialist: $117,700 - $151,300* Base pay is one part of your total compensation....
Senior Regulatory Affairs Specialist, IVDR
- Sunnyvale, CA (23 miles from Dublin, CA)
- 14 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 14 days ago
Workplace: Onsite in Sunnyvale, CA or Remote US Position Title: Senior Regulatory Affairs Specialist, IVDR Position Type: one-year month contract Pay rate: $47-50/ hour....
Senior Regulatory Affairs Specialist - Investigational Device Exemption (IDE)
- Sunnyvale, CA (23 miles from Dublin, CA)
- 18 days ago
- Sunnyvale, CA (23 miles from Dublin, CA)
- 18 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 and Compliance Analyst
- Palo Alto, CA (22 miles from Dublin, CA)
- 19 days ago
- Palo Alto, CA (22 miles from Dublin, CA)
- 19 days ago
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to...
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
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist 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 »