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 industry
RAPS RAC or ASQ (CQA/CQM/CQE) or other certifications preferred
Interested in hearing more?



Job Description
The 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 time

Pay Details: $130,000.00 to $140,000.00 per year

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To 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.