Senior Regulatory Affairs Specalist

Company: Real Staffing ( Learn More )

General Information
US-IL-Lake Forest
$11,500.00 - $135,000.00 /Year
4 Year Degree
Not Specified
Not Specified
Job Description

One of the world's leaders in medical device manufacturing, is looking for a Senior Regulatory Affairs Specialist.

The Senior Regulatory Affairs Specialist will be responsible for guiding the production, marketing, and distribution of Class I and II electromechanical devices and disposables to verify that all functions are in compliance.

Core Responsibilities

* Compile and maintain 510(k), Technical File and other regulatory files, in a format consistent with requirements. Complete memos to file assessing changes.
* Project Management for compliance projects
* Complete product and facility registrations, license extensions and amendments, renewals according to agreed timeline, ensure approvals in a timely manner
* Unique Device Identifier (UDI) implementation and maintenance

Core Requirements

* 6-10 years of regulatory experience in medical device industry with products marketed in the US, Canada, and EU.
* Minimum of a Bachelor's Degree
* Proficient in 21 CFR 820 and the Medical Device Directive and Canadian Medical Device Regulations

Apply now by forwarding your resume and/ or reaching out to me on the details below.

Sthree US is acting as an Employment Agency in relation to this vacancy.

Job Requirements