Regulatory Affairs Specialist Jobs in California
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.
Conducts internal audits for 340B program compliance. Identifies gaps in program performance and assists in development of action plans to resolve identified issues....
Job Title: Regulatory Affairs Specialist Looking for a candidate that has at least 2-5 years of regulatory experience within Medical Device Class II....
Senior Regulatory Affairs Specialist Vascular (on-site)
- Santa Clara, CA
- 1 day ago
- Santa Clara, CA
- 1 day ago
This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division....
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,...
General Atomics (GA), and its affiliated companies, is one of the world's leading resources for high-technology systems development ranging from the nuclear fuel cycle to remotely piloted...
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkPrincipal Regulatory Affairs Specialist - US New Product Introduction - Diabetes Care (on-site)
- Alameda, CA
- 2 days ago
- Alameda, CA
- 2 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)....
Summary The BSA/Title 31 Compliance Analyst will perform reviews and analytical tasks for the property to achieve compliance with BSA/TITLE 31 C.F.R. rules and regulations. This position will...
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA
- 3 days ago
- Pleasanton, CA
- 3 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...
Are you looking to catapult your career by driving high-impact transformation with household brands? Do you crave an entrepreneurial, fast paced and engaging growth assignment working with...
Department: Affordable Housing | Equity - Asset Management We are Walker & Dunlop. We are one of the largest providers of capital to the commercial real estate industry, enabling real estate...
Remote WorkJob Description: Pacific Life is investing in bright, agile, and diverse talent to contribute to our mission of innovating our business and creating superior customer experience. We are actively...
Regulatory Affairs Specialist - Valencia, CA Kelly Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position (approx. 1 year) at a biotech company in Valencia, CA, with...
General Atomics (GA), and its affiliated companies, is one of the worlds leading resources for high-technology systems development ranging from the nuclear fuel cycle to remotely piloted aircraft,...
Job Summary: The Contractual Compliance Analyst (Analyst) is responsible for conducting in-depth investigations and enforcement actions related to the Registrar Accreditation Agreement, Registry...
Demographic Data for California
Moving to California? Find some basic demographic data about California below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in California
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in California 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
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- 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
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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