Regulatory Affairs Specialist
Job Description
R&D Partners is seeking to hire a Regulatory Affairs Specialist III in Pleasanton, CA.
Your main responsibilities as a Regulatory Affairs Specialist III:
Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.
Responsible for drafting submissions and maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.
Manages submission activities for a variety of device regulatory approvals including the IVDR/CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer.
Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.
What we are looking for in a Regulatory Affairs Specialist III:
Bachelor's Degree B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred.
Regulatory Affairs Certification preferred.
5 years of experience in regulatory affairs in IVD or medical devices. IVD device experience is preferred.
Experience with Microsoft based applications and general knowledge of PC functions is necessary.
Experience with regulatory submissions including IVDR CE submission, IDE, 510(k), and PMA submissions is preferred.
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
Medical insurance PPO, HMO & HSA
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
Pay Scale:
$117,998 $156,000 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.