Regulatory Affairs Specialist Jobs in San Marcos, 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.
(Contract) Regulatory Affairs Specialist
- Carlsbad, CA (7 miles from San Marcos, CA)
- 2 days ago
- Carlsbad, CA (7 miles from San Marcos, CA)
- 2 days ago
Provide regulatory guidance to quality systems, manufacturing, marketing and product development groups Represent regulatory on various projects supporting compliance Provide regulatory guidance to...
CMC Regulatory Affairs Specialist
- Carlsbad, CA (7 miles from San Marcos, CA)
- 45+ days ago
- Carlsbad, CA (7 miles from San Marcos, CA)
- 45+ days ago
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. As part of Siemens Healthineers, PETNET is at the forefront of radiopharmaceuticals and molecular imaging....
Sr. Regulatory Affairs Associate
- Carlsbad, CA (7 miles from San Marcos, CA)
- 60+ days ago
- Carlsbad, CA (7 miles from San Marcos, CA)
- 60+ days ago
The Senior Regulatory Affairs Associate provides regulatory guidance to assists in the development and execution of effective regulatory affairs strategies and regulatory filings for product...
Demographic Data for San Marcos, CA
Moving to San Marcos, CA? Find some basic demographic data about San Marcos, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in San Marcos, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in San Marcos, 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
- Internal Control
- Reimbursement
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Analytical Skills
- Process Improvement
- Military Background
- Auditing
- Implementation
- Investigation
- Verbal Communication
- Written Communication
- Data Analysis
- Documentation
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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