Clinical Affairs Specialist in Bothell, WA at Volt

Date Posted: 8/2/2018

Job Snapshot

  • Employee Type:
  • Location:
    Bothell, WA
  • Duration:
    16 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
    $35.0 - $45.0/Hour
  • Contact Name
    Volt Branch
  • Phone

Job Description

Clinical Affairs Specialist

This company located in Bothell, WA (near Seattle) which is a global medical device manufacturer known for their BladderScan and GlideScope devices is seeking a Clinical Affairs Specialist for a contract role. The company’s mission is to provide innovative and specialized medical solutions that empower healthcare providers to improve and extend patients’ lives. Creates and conducts cross-functional reviews of specified design documents.

Reviews and approves cross-functional design documents that feed user specification and validation documents. Routes documents appropriately through our doc control system. Works with outside recruiting agencies to identify recruits for validation testing for several products in development. Works with engineering to gather appropriate testing artifacts and coordinates user testing validation logistics. Conducts user testing validation. Drafts user testing reports per regulatory guidelines. Compiles final validation reports that include the use and human factors report as well as the other user need items validated through analysis (i.e., verification which will be performed by another team).

Document Deliverables: Use Specification. Validation Plan (includes user needs and foreseeable critical use errors). Validation protocol (includes anything validated through user testing). Use and human factors report/ Validation report (includes material from two base reports, one owned by the clinical contractor and one owned by compliance engineering).

Job Requirements:

The ideal candidate should possess clinical affairs medical device experience for Class I and II products. Validation experience needed.

Familiarity with Use and Human Factors standards and regulatory guidelines regarding proper validation procedures.

Length of assignment: 4 months maybe longer                    Pay Rate: DOE

Key points:

The hiring manager is seeking someone with at least 5 years of medical device experience. Must have experience with clinical trials and validation experience. Documentation experience. Must be able to work in a highly collaborative environment. Must be flexible, have open communications skills and innovative. Human Factors experience a plus.

Volt is an Equal Opportunity Employer