About us:

We are Simple HealthKit, a consumer-focused health tech startup focused on innovation and delivering fast and rapid diagnostic solutions for all. Our customers and their patient populations can order kits, test themselves, track their results, and even get meds delivered. We’re breaking down barriers and providing affordable solutions to allow better health for everyone. And not “everyone,” as in “everyone making a good salary”, or who live in a specific zip code or have a specific health plan.

Everyone as in everyone.

We’re operating in a $100 billion market, and we’re backed by the same investors who invested in Amazon, Genentech, and Instacart. This is a great time to join Simple HealthKit!

About the role:

As we grow, we’re looking for someone to oversee all quality and regulatory aspects related to the design, development, manufacturing, registration, and commercialization of our current and future product lines. You’ll be a vital part of the organization, working and interacting with every department in the company, closely managing the effectiveness of the quality management systems, and conducting supplier selection with annual audits of suppliers and contract manufacturers as well as internal audits to monitor the effectiveness of the quality management system. We work with all regulatory bodies - CLIA, CAP, and FDA.

You’ll also:

  • Work closely with interdisciplinary teams to ensure that products are designed, developed, and manufactured in accordance with internal procedures and meet the requirements set forth in the application regulations and standards.
  • Act as our primary liaison with regulatory agencies and certifying bodies for all regulatory submissions, responses to inquiries, site inspections, and all matters regarding compliance with quality system requirements and product complaints/problems.
  • Coordinate the review of product labeling and advertising including, but not limited to, marketing promotional materials.
  • Establish and implement company-wide documentation procedures used in fulfilling Quality System Regulation (QSR) and Medical Device Directive (MDD) requirements.
  • Review all MDR and Vigilance reporting to regulatory authorities.
  • Direct interactions with FDA, State Department of Health, and the Notified Body during company inspections.

This role is important to Simple HealthKit and our mission to impact communities. So it pays at or above market rate and includes health care, a 401(K), and unlimited PTO. Equity is a part of every package.

Requirements:

  • BA/BS degree in a science or related field
  • 2+ Years of related work experience
  • Demonstrated experience with Risk Management Standard ISO 14971
  • Demonstrated knowledge of current and amended EN ISO 13485, EN ISO 14971, MDD 93/42/EEC, CMDR SOR/98-282, and FDA QSR

Preferences:

  • Experience with Class II devices
  • Experience with at-home testing both FDA and LDT tests

Does this sound like the job for you? If so, please take the next step and apply today. Our recruiting team reviews every application within 48 hours, and you will hear back from us quickly.

If selected for this job, you will be required to verify that you have been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Simple HealthKit is an Equal Opportunity Employer. We want our company to look like the clients we serve and the world we live in.