Regulatory Affairs Specialist Jobs in Solana Beach, CA
- San Diego, CA (19 miles from Solana Beach, CA)
- 7 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 7 days ago
Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), internal preparation and agency meetings....
- San Diego, CA (19 miles from Solana Beach, CA)
- 13 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 13 days ago
submissions including: US 510(k), pre-submissions, LTF, MDDS change assessment Health Canada amendments CE-marked products under EU MDR: change notifications, technical file update and submissions,...
Remote WorkRegulatory Affairs Coordinator
- San Diego, CA (19 miles from Solana Beach, CA)
- 15 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 15 days ago
We're looking for people who put their innovation to work to advance our success - and their own. Join an organization that ensures a more secure world through connecting and protecting our...
Staff Regulatory Affairs Associate
- San Diego, CA (19 miles from Solana Beach, CA)
- 20 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 20 days ago
As Staff Regulatory Affairs Specialist, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories...
Remote WorkStaff Regulatory Affairs Specialist
- San Diego, CA (19 miles from Solana Beach, CA)
- 21 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 21 days ago
Job Overview As a Staff Regulatory Affairs Specialist, you will play a crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non-medical devices, medical devices...
Staff Specialist Regulatory Affairs (Hybrid)
- San Diego, CA (19 miles from Solana Beach, CA)
- 22 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 22 days ago
Prepare, submit, and manage regulatory submissions for SaMD products. Evaluate the impact of changes to SaMD functionality and determine whether submissions or notifications are required....
Staff Regulatory Affairs Specialist, Software
- San Diego, CA (19 miles from Solana Beach, CA)
- 22 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 22 days ago
SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and its no small...
Document Compliance Analyst (Remote)
- San Diego, CA (19 miles from Solana Beach, CA)
- 26 days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 26 days ago
A top employer in the mortgage industry is looking for a Document Compliance Analyst to join their team in a fully remote role. This person will be responsible for ensuring compliance with...
Remote WorkSenior Specialist Regulatory Affairs - Incubation & Growth
- San Diego, CA (19 miles from Solana Beach, CA)
- 45+ days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 45+ days ago
Proven experience leading or coordinating global regulatory submissions (e.g., 510(k), CE Marking, TGA ARTG)....
Staff Regulatory Affairs Specialist (Hybrid)
- San Diego, CA (19 miles from Solana Beach, CA)
- 60+ days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 60+ days ago
submission....
Staff Regulatory Affairs Specialist - SaMD
- San Diego, CA (19 miles from Solana Beach, CA)
- 90+ days ago
- San Diego, CA (19 miles from Solana Beach, CA)
- 90+ days ago
Job Description Summary As Staff Regulatory Affairs Specialist, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated...
Demographic Data for Solana Beach, CA
Moving to Solana Beach, CA? Find some basic demographic data about Solana Beach, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Solana Beach, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Solana Beach, 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
- ICH Guidelines
- 21 CFR 820
- ISO 13485
- Quality Systems
- Quality Management Systems
- Validation
- Medical Device Sales
- Microsoft Visio
- Legal Research & Writing
- FDA Regulations
- Corrective Actions & Preventive Actions
- Root Cause Analysis
- Continuous Improvement
- Standard Operating Procedures
- Product Development
- Strategy Development
- Reimbursement
- Risk Management
- Engineering
- Implementation
- Military Background
- Analytical Skills
- Written Communication
- Auditing
- Process Improvement
- Microsoft Outlook
- Documentation
- Verbal Communication
- Collaboration
- Interpersonal Skills
- Investigation
- Reporting
- Bachelor's Degree
- Policy Development
- Microsoft PowerPoint
- Regulations
- Filing
- Education Experience
- Project Management
- Time Management
- Research Skills
- Microsoft Office
- Computer Skills
- Staff Supervision
- Organization
- Microsoft Excel
- Problem Solving
- Scheduling
- Leadership
- Communication Skills
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