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Regulatory Specialist (Medical Software)

Company Overview

Idea Evolver specializes in leveraging market research and audience intelligence to help companies design and launch targeted products and high growth marketing campaigns quickly.

Notable clients include Dannon, AstraZeneca, United Therapeutics, and K. Hovnanian Homes.

Position Overview

We are looking for a talented and experienced Regulatory Specialist who can support our software development efforts by managing, maintaining, and writing QMS and Project Validation documentation.

You would be spending a lot of time preparing our Verification and Validation deliverables for FDA regulated projects, maintaining our company QMS, and helping to define and implement SDLC validation activities used on our projects for clients in the Pharmaceutical and Bio Tech spaces. 

This position is based in Brooklyn, NY.

Responsibilities

  • Write Verification and Validation deliverables for software projects
  • Manage and maintain our in-house Quality Management System
  • Work with our VP of Product to help ensure that we’re following GxP Practices and complying with standards such as ISO 9001, ISO 13485, IEC 62304, ISO 14971 and CFR Part 820.30

Qualifications

  • Familiarity with ISO 9001, 13485, and/or 14971
  • Familiarity with CFR 820.30
  • Experience developing or auditing Quality Management Systems
  • Experience in FDA Regulatory environments preferred
  • Experience/familiarity with the V&V activities related to Software As a Medical Device Preferred

Personal Attributes

  • Comfortable writing documentation from scratch or following pre-defined templates
  • Able to distill complex technical concepts into clear written and verbal messages for both technical and non-technical audiences.
  • Ability to prioritize and coordinate multiple tasks.
  • Ability to work independently

Compensation and Benefits

  • Competitive Salary
  • Excellent health and dental
  •  401k
  • 15 paid days off plus holidays
  • Workstation includes the newest equipment
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