Sr. Quality Compliance Engineer
Company: PDS Tech Commercial, Inc.
Location: Redmond
Posted on: April 26, 2024
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Job Description:
PDS Tech is looking for a Regulatory Affairs Specialist for our
Medical Device client in Redmond, Washington .6 mo+ contract
assignment (possibility to go direct)Monday to Friday; 8:00 AM to
4:30 PM -BS and 5+ years regulatory experience with FDA and
international product registration regulations and a strong
knowledge of the medical device industryRAPS RAC or ASQ
(CQA/CQM/CQE) or other certifications preferredInterested in
hearing more? - Send resume with contact to for considerationJob
DescriptionThe Regulatory Affairs Specialist is required to support
product registrations in international markets. Requesting
documentation from the FDA as well as legalizing USA documentation,
e.g., the Apostille process, for international markets.
Establishing a reliable method to ensure timely international
market registration. Performs labeling reviews to ensure
conformance to regulatory requirements. Additional regulatory and
quality management system duties may be assigned. -Job
Responsibilities:---Fulfill open international product registration
regulatory documentation requests---Establish an international
product registration regulatory plan---Establish a reliable method
to identify country-specific documentation and how to accomplish
requirements like document authentication, e.g., the Apostille
process---Establish a method so the sales and distribution teams
know what countries are approved for distribution---Request FDA
Certificates to Foreign Governments---Facilitate the legalization
of the USA documentation process, e.g., the Apostille process to
ensure international product registrations---Provide regulatory
documentation to the shipping team for international product
distribution---Reviews promotional and advertising labeling
material and provides regulatory direction for communications to
the sales force and training department relating to marketed
products---Create and update technical documents, clinical
evaluation reports, post-market clinical follow-up, and periodic
safety update reports following adverse event reportability
requirements.---Stay informed of new and pending requirements by
researching regulatory requirements germane to the company---Other
quality assurance and regulatory affairs assignments and projects
as directed -Position Qualifications:---Bachelor's degree required
(life science or engineering preferred)---Minimum five years of
regulatory experience with FDA and international product
registration regulations and a strong knowledge of the medical
device industry---FDA 510(k) and technical file submission
experience preferred.---Extensive experience with the legalization
of the USA documentation process, e.g., the Apostille process to
ensure international product registrations---RAPS RAC or ASQ
(CQA/CQM/CQE) or other certification preferred---Regulatory project
management experience preferred---Strong communication, team
building, written and verbal communication skills, and
interpersonal & problem-solving skills---Ability to exercise sound
judgment in prioritizing workflow---Ability to establish sound
working relationships with different types of people with differing
levels of skill and background is essential---Detail &
deadline-oriented, well organized; demonstrated ability to
organize, plan, and schedule tasks and communicate the status of
projects on timePay Details: $130,000.00 to $140,000.00 per year
Equal Opportunity Employer/Veterans/DisabledTo read our Candidate
Privacy Information Statement, which explains how we will use your
information, please navigate to
https://www.pdstech.com/candidate-privacy /> The Company will
consider qualified applicants with arrest and conviction records
subject to federal contractor requirements and/or security
clearance requirements.
Keywords: PDS Tech Commercial, Inc., Sammamish , Sr. Quality Compliance Engineer, Engineering , Redmond, Washington
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