Regulatory Affairs Specialist Jobs in Foothill Ranch, 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.
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 11 hours ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 11 hours ago
Regulatory Affairs Specialist II Job Description A Regulatory Affairs Specialist II plays a pivotal role in ensuring that the company's medical devices comply with regulatory requirements throughout...
Regulatory Affairs Coordinator - Hybrid
- Orange, CA (11 miles from Foothill Ranch, CA)
- 1 day ago
- Orange, CA (11 miles from Foothill Ranch, CA)
- 1 day ago
Regulatory Affairs Coordinator - Hybrid Req ID: 90381 Location: Irvine, California Division: School of Medicine Department: Cancer Center Position Type: Full Time Salary Range Minimum: USD...
Regulatory Affairs Specialist II
- Lake Forest, CA (8 miles from Foothill Ranch, CA)
- 2 days ago
- Lake Forest, CA (8 miles from Foothill Ranch, CA)
- 2 days ago
Seeking a detail-oriented and collaborative Regulatory Affairs Specialist II to support global registration efforts and ensure compliance with international medical device regulations....
REMOTE Loan Servicing Compliance Analyst, I
- Anaheim, CA (19 miles from Foothill Ranch, CA)
- 2 days ago
- Anaheim, CA (19 miles from Foothill Ranch, CA)
- 2 days ago
Come join our amazing team and work remote from home!** The Loan Servicing Compliance Analyst I will be responsible for the provisioning documentation for various audit and exam documentation....
Remote WorkREMOTE Loan Servicing Compliance Analyst, I
- Anaheim, CA (14 miles from Foothill Ranch, CA)
- 3 days ago
- Anaheim, CA (14 miles from Foothill Ranch, CA)
- 3 days ago
Come join our amazing team and work remote from home! The Loan Servicing Compliance Analyst I will be responsible for the provisioning documentation for various audit and exam documentation. Also...
Remote WorkRegulatory Affairs Specialist I
- Lake Forest, CA (8 miles from Foothill Ranch, CA)
- 3 days ago
- Lake Forest, CA (8 miles from Foothill Ranch, CA)
- 3 days ago
Job Title: Regulatory Affairs Specialist I Location: Remote 100% Duration: 24 months Interviews: 1 (Panel) - Maybe 2 Must haves: Bachelor's Degree - no specific Field of study....
- Newport Beach, CA (12 miles from Foothill Ranch, CA)
- 15 days ago
- Newport Beach, CA (12 miles from Foothill Ranch, CA)
- 15 days ago
Job Description: Providing for loved ones, planning rewarding retirements, saving enough for whatever lies ahead our policyholders count on us to be there when it matters most. Its a big ask, but...
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 20 days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 20 days ago
auditing and benefits analysis Must have strong Excel skills, including experience with VLOOKUP, pivot tables, MATCH, and conditional formatting RESPONSIBILITIES: Administer and track daily job setup...
Remote IT Quality Assurance and Compliance, Analyst
- Anaheim, CA (14 miles from Foothill Ranch, CA)
- 24 days ago
- Anaheim, CA (14 miles from Foothill Ranch, CA)
- 24 days ago
Come join our amazing team and work remote from home! What youll do: Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring that...
Remote WorkSenior Regulatory Affairs Specialist - Urology
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 29 days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 29 days ago
, ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies....
Regulatory Affairs Specialist III - Urology
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position supporting our rapidly growing active implantable device portfolio....
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
Company: Kelly Services Location: Irvine, CA Career Level: Associate Industries: Recruitment Agency, Staffing, Job Board Description Job Title: Sr Analyst, Commercial Operations Department:...
Remote WorkCompliance Analyst - Audit & Certifications
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
Compliance Analyst - Audit & Certifications Apply now SUMMARY We are seeking a detail-oriented and proactive Compliance Analyst to join our growing team. In this role, you will be instrumental in...
Senior Regulatory Affairs Specialist
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
- Irvine, CA (5 miles from Foothill Ranch, CA)
- 30+ days ago
A Day in the Life The Sr Regulatory Affairs Specialist will play a key role in sustaining the current product portfolio....
Principal Controls & Compliance Analyst (remote)
- Santa Ana, CA (11 miles from Foothill Ranch, CA)
- 30+ days ago
- Santa Ana, CA (11 miles from Foothill Ranch, CA)
- 30+ days ago
Principal Controls & Compliance Analyst (remote) First American Financial Corporation - 3.8 Santa Ana, CA Job Details $109,650 - $146,175 a year 11 hours ago Benefits Employee stock purchase plan...
Remote WorkDemographic Data for Foothill Ranch, CA
Moving to Foothill Ranch, CA? Find some basic demographic data about Foothill Ranch, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Foothill Ranch, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Foothill Ranch, 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 Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Distribution
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Interpersonal Skills
- Reporting
- Collaboration
- Policy Development
- Filing
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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