Regulatory Affairs Specialist Jobs in Rancho Santa Margarita, 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.
Sr. Specialist, Regulatory Affairs
- Metagenics
- Aliso Viejo, CA (6 miles from Rancho Santa Margarita, CA)
- 23 hours ago
- Aliso Viejo, CA (6 miles from Rancho Santa Margarita, CA)
- 23 hours ago
Prior experience operating in a technical environment, knowledge of quality management principles and systems, understanding of manufacturing and packaging in a pharmaceutical environment International...
In PersonSpecialist, Regulatory Affairs Surgical
- Edwards Lifesciences
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 5 days ago
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 5 days ago
May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files) Provide...
In PersonEarned Value Compliance Analyst (Subject Matter Expert)
- Boeing
- Huntington Beach, CA (22 miles from Rancho Santa Margarita, CA)
- 6 days ago
- Huntington Beach, CA (22 miles from Rancho Santa Margarita, CA)
- 6 days ago
Job Description At Boeing, we innovate and collaborate to make the world a better place. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive,...
Hybrid- Paramount Residential Mortgage Group
- Corona, CA (17 miles from Rancho Santa Margarita, CA)
- 13 days ago
- Corona, CA (17 miles from Rancho Santa Margarita, CA)
- 13 days ago
Prepare and maintain exam-ready loan files and support documentation for internal audits, regulatory exams, and third-party reviews....
In PersonPrincipal Regulatory Affairs Specialist - Cardiac Ablation
- Biotronik
- Tustin, CA (14 miles from Rancho Santa Margarita, CA)
- 18 days ago
- Tustin, CA (14 miles from Rancho Santa Margarita, CA)
- 18 days ago
Principal Regulatory Affairs Specialist - Cardiac Ablation BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management, electrophysiology...
Hybrid Full TimeAssociate Labeling Specialist Regulatory Affairs
- Applied Medical
- Rancho Santa Margarita, CA
- 30+ days ago
- Rancho Santa Margarita, CA
- 30+ days ago
Familiarity with Quality Systems Regulations (QSRs), Good Manufacturing Practices (GMPs), and ISO standards for medical devices....
In PersonSenior Regulatory Affairs Specialist, Post Market
- Kelly Services
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 30+ days ago
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 30+ days ago
Senior Regulatory Affairs Specialist, Post Market Apply Now Applied To save a job sign in or get started Job ID: 10212058 Posted today Back Irvine, CA, US Scientific Bachelors Degree Full Time, Direct...
In PersonJunior Regulatory Affairs Specialist
- Pro-Dex, Inc.
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 30+ days ago
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 30+ days ago
Quality Assurance/Regulatory Affairs Specialist MENTAL, PHYSICAL AND VISUAL DEMANDS: Position entails some travel. Ability to work under pressure of deadlines is necessary....
In PersonSupply Chain Compliance Analyst
- ANDURIL INDUSTRIES
- Costa Mesa, CA (17 miles from Rancho Santa Margarita, CA)
- 30+ days ago
- Costa Mesa, CA (17 miles from Rancho Santa Margarita, CA)
- 30+ days ago
This role translates complex regulatory requirements-FAR/DFARS, ITAR, export controls, and customer flow-downs-into clear, executable processes that withstand internal audits, customer scrutiny, and...
In Person- Assa Abloy
- Lake Forest, CA (6 miles from Rancho Santa Margarita, CA)
- 30+ days ago
- Lake Forest, CA (6 miles from Rancho Santa Margarita, CA)
- 30+ days ago
The Trade Compliance Analyst supports and executes the companys import trade compliance program, with responsibility for determining product classifications, country of origin, and tariff...
In PersonSenior Specialist, Regulatory Affairs Operations
- JENAVALVE TECHNOLOGY INC
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 30+ days ago
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 30+ days ago
Working knowledge of quality systems and relationship to business. Ability to work in a fast-paced, technically challenging environment where drive is critical to success....
In Person- Paramount Residential Mortgage Group
- Corona, CA (17 miles from Rancho Santa Margarita, CA)
- 30+ days ago
- Corona, CA (17 miles from Rancho Santa Margarita, CA)
- 30+ days ago
Prepare and maintain exam-ready loan files and support documentation for internal audits, regulatory exams, and third-party reviews....
RemoteRegulatory Affairs Associate I
- Mindlance
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 45+ days ago
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 45+ days ago
Regulatory Affairs Associate I#26-11111 $33.03-$35.16 per hour Irvine, CA All On-site Job Description Job Description: Contributions will include: generate graphs and figures for journal...
In Person- Nihon Kohden
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 45+ days ago
- Irvine, CA (11 miles from Rancho Santa Margarita, CA)
- 45+ days ago
The Regulatory Affairs Specialist is responsible for investigating and supporting regulatory policy necessary to obtain regulatory approval for the organizations products Work with RA Leadership and...
In PersonSenior Consumer Compliance Analyst
- S&T Bank
- Santa Ana, CA (16 miles from Rancho Santa Margarita, CA)
- 60+ days ago
- Santa Ana, CA (16 miles from Rancho Santa Margarita, CA)
- 60+ days ago
Location: 800 Philadelphia Street Indiana, Pa 15701 or: 358 North Shore Drive Pittsburgh, Pa 15212 or: 7660 Saltsburg Rd Pittsburgh, PA 15239 or: 210 Portage Trail Extension W Suite 101 Cuyahoga...
In PersonDemographic Data for Rancho Santa Margarita, CA
Moving to Rancho Santa Margarita, CA? Find some basic demographic data about Rancho Santa Margarita, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Rancho Santa Margarita, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Rancho Santa Margarita, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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