Job Description

Company Overview Idea Evolver specializes in marketing and custom software development to help companies design and launch targeted products and high growth marketing campaigns quickly. Notable clients include Dannon, AstraZeneca, United Therapeutics, and Webtoon. Position Overview We are looking for a talented and experienced Software as a Medical Device (SaMD) Compliance Associate who can support our software development efforts by managing, maintaining, and writing QMS and Project Validation documentation, as well as has a background in Artificial Intelligence/Machine Learning. This person would be responsible for 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. 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\xe2\x80\x99re 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
• Preferable - experience in FDA Regulatory environments
• Preferable \xe2\x80\x93 experience/familiarity with the process and V&V activities related to Software as a Medical Device
• 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
• 401k plus company match
• 20 paid days off plus holidays

Job Type: Full-time Pay: $100,000.00 - $130,000.00 per year Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Experience:

• Medical Device: 3 years (Required)

Work Location: Remote

• Health insurance