Regulatory Affairs Specialist Jobs in Carlsbad, 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.
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....
- La Jolla, CA (20 miles from Carlsbad, CA)
- 10 days ago
- La Jolla, CA (20 miles from Carlsbad, CA)
- 10 days ago
Senior SOX Compliance Analyst Salary: $95120k Location: San Diego Hybrid (2 days on-site) Were working with a well-established and rapidly expanding biotechnology client in San Diego thats looking...
CFR 820 (Design Controls) and ISO 13485 for Quality Management Systems to ensure regulatory compliance across product lifecycle stages; 4) 2 years of experience applying ISO 14971 for risk management...
The Regulatory Affairs Specialist will support the company's regulatory compliance efforts, ensuring that new and existing products meet global regulatory requirements....
- La Jolla, CA (20 miles from Carlsbad, CA)
- 17 days ago
- La Jolla, CA (20 miles from Carlsbad, CA)
- 17 days ago
About Vaco: Vaco provides expert consulting, permanent placement, executive search, and strategic staffing for companies around the world, in the areas of accounting, finance, operations,...
Regulatory Affairs Specialist - Vista, CA
- Vista, CA (1 mile from Carlsbad, CA)
- 18 days ago
- Vista, CA (1 mile from Carlsbad, CA)
- 18 days ago
Regulatory Affairs Specialist Summary: This position is responsible for handling time sensitive Regulatory documents in accordance with appropriate regulatory agencies and internal company procedures...
Senior SOX Compliance Analyst - Hybrid
- La Jolla, CA (20 miles from Carlsbad, CA)
- 45+ days ago
- La Jolla, CA (20 miles from Carlsbad, CA)
- 45+ days ago
About Vaco: Vaco provides expert consulting, permanent placement, executive search, and strategic staffing for companies around the world, in the areas of accounting, finance, operations,...
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...
- Del Mar, CA (13 miles from Carlsbad, CA)
- 90+ days ago
- Del Mar, CA (13 miles from Carlsbad, CA)
- 90+ days ago
Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics...
Demographic Data for Carlsbad, CA
Moving to Carlsbad, CA? Find some basic demographic data about Carlsbad, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Carlsbad, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Carlsbad, 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
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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