Senior Regulatory Affairs Specialist in Seattle, WA at Apex Life Sciences

Date Posted: 3/14/2018

Job Snapshot

Job Description

Apex Life Sciences is looking for a Senior Regulatory Affairs Specialist for a medical device client located in Seattle! Please see below and apply if interested!


As a Sr. Regulatory Affairs Specialist, you will be responsible for obtaining US and OUS product clearances as well as maintaining Technical Files and Establishment Licenses. You will also participate in worldwide Field Actions as a key contributor. In addition, you will communicate significant design changes outwardly to our client's partners, while also communicating changes in the evolving regulatory landscape inwardly to the product development team. 


  • Responsible for supporting Regulatory Affairs domestically as well as European registrations and submissions, technical file maintenance and recall coordination.
  • Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
  • Manage response for regulatory requests from customers, distributors or regulatory agencies.
  • Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
  • Maintain company registrations and device listings in the US, Canada, and the EU.
  • Support/maintenance of technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
  • Recall coordinator for product recalls.  
  • Support and report departmental metrics and reports to executive management.
  • Provides support and backup for other QA/RA functions.
  • Supports internal/external audits and regulatory inspections.


  • Bachelor's Degree (B.S.) from a four-year college or university in Engineering, Bio-Medical Engineering, Sciences or related field.
  • Minimum 6 years of Regulatory Affairs work experience in medical device (Class II and Class III).
  • Strong knowledge and experience with 510(k) preparations and submissions required.
  • Must have demonstrated experience with submissions in Canada and EU.
  • Experience with international countries a plus.
  • Current knowledge of FDA and International quality system regulations required.
  • Specific experience following Device Design Controls and Risk Management Processes.


  • The employee is occasionally required to travel by car and/or airplane to other company facilities or other remote locations as required.