Regulatory Affairs Manager or Quality Assurance Manager
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Job Location:
Ventura, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
- Application Deadline: Dec. 31 2025
- Ventura
- On-site
Job Description
Essential Functions:
regulatory submissions/registrations/licensing documentation.
that processes needed for regulatory compliance are established implemented and maintained and continuously improved.
and coordinate all positions related to Regulatory Affairs.
product and product concepts for compliance with the appropriate governing regulatory requirements.
international authorized distributors.
company for compliance with Regulatory Standards and the Quality Management System (QMS).
as the primary contact with State Federal and International Agencies (Management Representative). Primary lead (host) for regulatory and notified body/ISO Registrar audits.
as the primary contact with Notified Body/ISO Registrar and applicable foreign distributor regulatory departments regarding applicable product issues product changes or quality system changes.
and report to top management the applicable regulatory requirements.
I 0. Advise on regulatory issues. Ensure the promotion of regulatory requirements throughout the organization.
Provide regulatory guidance to departments and communicate regulatory information and ensure that the information is interpreted correctly.
prepares and conducts Management Review meetings.
for regulatory issues
regulatory documentation review
and implement QMS and applicable regulatory training.
(implement maintain and continuously improve) the internal audit system.
(implement maintain and continuously improve) the customer Complaints/Feedback System.
(implement maintain and continuously improve) the regulatory adverse event reporting system.
(implement maintain and continuously improve) the product recall and advisory notice systems.
(implement maintain and continuously improve) clinical evaluations.
schedules and follows up on QMS audits (external & internal and regulatory).
OEM customer audits.
define and defend regulatory policy.
employees making decisions regarding hiring firing discipline and performance evaluations.
with coworkers at all levels
to be present in the work place during scheduled work hours.
to work independently to perform daily operating tasks.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
About the company Employbridge is recognized by Staffing Industry Analysts (SIA) as America’s largest industrial staffing firm. Combining our national scale and local expertise with the speed and efficiency of our Bluecrew platform, we put more than 440,000 people to work annually, fr ... View more
